HIV Infection
Conditions
Brief summary
This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of adolescents and young adults with HIV infection in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) who are currently being treated with cART that includes tenofovir disoproxil fumarate (TDF) as one component of the regimen that includes at least three Food and Drug Administration (FDA)-approved antiretroviral (ARV) drugs for at least 180 days.
Detailed description
This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of adolescents and young adults with HIV infection in the ATN who are currently being treated with cART that includes TDF as one component of the regimen that includes at least three Food and Drug Administration (FDA)-approved ARVs for at least 180 days. Subjects must have at least one documented viral load that is below 200 copies/mL that is collected following initiation of TDF containing cART and greater than 90 days prior to randomization; no viral load above 200 copies/mL if measured within the 90 days prior to randomization; and an HIV viral load obtained at screening that is below 200 copies/mL. Treatment assignments will be balanced by subject sex at birth, age (\<20 years vs. \>=20 years), and race (African American vs. other). Enrolled subjects will be randomized to receive vitamin D3 50000 IU or matching placebo, given orally every four weeks by DOT. In addition to the randomized study agent, all subjects will receive a MVI to be taken orally once daily. This standard MVI will contain ingredients not to exceed 600 IU of vitamin D3 and 200 mg Ca. Dual energy x-ray absorptiometry (DXA) measurement of bone mineral content (BMC)/bone mineral density (BMD) of whole body, spine, and hip, will be performed at baseline and study weeks 24 and 48. Blood and urine sampling to assess the Ca-phosphorous (PO4) axis, parathyroid hormone (PTH)-FGF23-vitamin D signaling, bone turnover, and renal glomerular and tubular function will occur at baseline and study weeks 12, 24, and 48. Blood samples to measure Gluc homeostasis will be drawn at baseline and week 48, and will be run by batch analysis. Safety, measured by serum calcium (SCa) and serum creatinine (SCr), will be monitored by subject's record review at study sites since these labs will generally be measured as a part of routine clinical care. The Adolescent Medicine Trials Network for HIV/AIDS Interventions 109 (ATN 109) study will use the SCa and SCr values obtained within 10 weeks at the time of the visit beginning at the baseline visit. If these evaluations were not performed within the prior 10 weeks they will be drawn at the time of each visit. Viral load and cluster of differentiation 4 (CD4) cell count results will be recorded for this study, ATN 109, at screening, baseline and study weeks 12, 24, 48, and Post-Week 48 provided the evaluations were done within the protocol specified timeframe. If the evaluations were not performed within the protocol specified timeframes they will be drawn at the time of the visit.
Interventions
DIETARY_SUPPLEMENTVitamin D3 50,000 IU
Group A: Vitamin D3 50,000 IU orally every four weeks by DOT
DIETARY_SUPPLEMENTVitamin D3 placebo
Group B: Vitamin D3 placebo orally every four weeks by DOT
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
To be considered eligible for enrollment, an individual must meet the criteria listed below at the time of randomization: NOTE: If the DXA scan is scheduled prior to randomization, all eligibility criteria must be met prior to performing the DXA scan. * Age 16 years and 0 days to 24 years and 364 days; * Behaviorally infected with HIV (e.g., sexual contact, injection drug use; not infected by perinatal transmission, blood transfusion, or at age younger than 9 years); * HIV-1 infection as documented in subject's medical record by at least one of the following criteria: * reactive HIV screening test result with an antibody based FDA-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 Indirect Immunofluorescence, Antibody Differentiation Assay (Multispot)); or * positive HIV-1 DNA polymerase chain reaction (PCR) assay; or * plasma HIV-1 quantitative RNA assay \>1,000 copies/mL; or * positive plasma HIV-1 RNA qualitative assay * Subjects must have at least one documented HIV viral load that is below 200 copies/mL collected following initiation of TDF containing cART and greater than 90 days prior to randomization; no HIV viral load above 200 copies/mL if measured within the 90 days prior to randomization; and an HIV viral load obtained at screening that is below 200 copies/mL. * Currently being treated for at least 180 days by the time of randomization with a TDF containing cART with at least 2 other FDA approved ARVs (NOTE: This may include a TDF-containing fixed drug combination medication); * Negative serum hepatitis B surface antigen (HBsAg) at screening or by history within 4 weeks prior to screening (see section 7.1.3); * Willingness and ability to remain on the same cART regimen for the duration of study participation; * Willingness and ability to participate in the study, follow all study procedures for the duration of study participation, and provide written informed consent or assent with parental permission, if applicable; and * For females of child-bearing potential, agreement to use a minimum of one proven-effective method of birth control and willingness to postpone pregnancy for the duration of study participation (see section 5.3.2 for permitted hormonal contraceptives)
Exclusion criteria
To be considered eligible for enrollment, an individual must not meet any of the criteria listed below at the time of randomization: NOTE: If the DXA scan is scheduled prior to randomization, all eligibility criteria must be met prior to performing the DXA scan. * Prior hypersensitivity to vitamin D; * History of sarcoidosis, arteriosclerosis, renal stones, glomerulonephritis, interstitial kidney disease, nephrotic syndrome, hypercalcemia, osteoporosis and/or other bone diseases, clinical diagnosis of hypoparathyroidism or hyperparathyroidism; * Lactation or pregnancy currently or within the past 24 weeks; * Chemotherapy or radiation therapy for malignancy within the past 12 months; * Known presence of GI disease that, in the opinion of the clinician, would interfere with study agent administration or absorption (e.g. Crohn's, Colitis); * For subjects ≥ 18 years, confirmed creatinine clearance \< 70 ml/min (estimated glomerular filtration rate (GFR) from SCr using Cockcroft and Gault (CG) equation) and for subjects \<18 years, confirmed creatinine clearance \< 70ml/min/1.73m2 (estimated GFR from SCr using Schwartz formula (see section 3.5). (Estimated GFR may be calculated using the formulae programmed on the ATN website); * SCa \> Upper Limit Normal (ULN) for local laboratory values (see section 7.1.3); * Active Grade 3 or higher clinical or laboratory toxicity except atazanavir (ATV) associated indirect hyperbilirubinemia (see section 9.5.2.2); * Weight is \> 350 pounds (lbs) or 159 kilograms (kgs); * Positive hepatitis C antibody by history or at screening (see section 7.1.3); and * Use of any medications as specified in sections 5.3.1, 5.3.3 and 5.4. * Females Only: Use of certain hormonal contraceptives as specified in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups | Baseline and wk 48 | Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups. Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 24 in PTH | Baseline and wk 24 | — |
| Change From Baseline to Week 48 in PTH | Baseline and wk 48 | — |
| Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | Baseline and week 48 | The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. |
| Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups | Baseline and week 24 | — |
| Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups | Baseline and week 48 | — |
| Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups | Baseline and week 24 | — |
| Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups | Baseline and week 48 | — |
| Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups | Baseline and week 24 | — |
| Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | Baseline and week 24 | The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. |
| Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups | Baseline and week 24 | The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. |
| Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups | Baseline and week 48 | The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. |
| Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups | Baseline and week 24 | — |
| Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups | Baseline and week 48 | — |
| Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups | Baseline and week 24 | The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. |
| Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups | Baseline and week 48 | The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. |
| Change From Baseline to Week 48 in BAP | Baseline and wk 48 | — |
| Change From Baseline to Week 12 in FGF23 | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in FGF23 | Baseline and wk 24 | — |
| Change From Baseline to Week 48 in FGF23 | Baseline and wk 48 | — |
| Change in SCr From Baseline to Week 12. | Baseline and week 12 | To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group; |
| Change in SCr From Baseline to Week 24. | Baseline and week 24 | To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group; |
| Change in SCr From Baseline to Week 48. | Baseline and week 48 | To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group; |
| Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin) | Baseline and 48 weeks | — |
| Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose) | Baseline and week 48 | — |
| Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)) | Baseline and week 48 | HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of \>2 for any insulin resistance, but normal values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance). |
| Change From Baseline to Week 12 in Serum Calcium (SCa) | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in Serum Calcium (SCa) | 24 weeks | — |
| Change From Baseline to Week 48 in Serum Calcium (SCa) | Baseline and wk 48 | — |
| Change From Baseline to Week 12 in CTX | Baseline and week 12 | — |
| Change From Baseline to Week 24 in CTX | Baseline and week 24 | — |
| Change From Baseline to Week 48 in CTX | Baseline and week 48 | — |
| Change From Baseline to Week 12 in OC | Baseline and week 12 | — |
| Change From Baseline to Week 24 in OC | Baseline and week 24 | — |
| Change From Baseline to Week 48 in OC | Baseline and wk 48 | — |
| Change From Baseline to Week 12 in BAP | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in BAP | Baseline and wk 24 | — |
| Change From Baseline to Week 12 in Actual Free 1,25-OHD | Baseline and wk 12 | Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L |
| Change From Baseline to Week 24 in Actual Free 1,25-OHD | Baseline and wk 24 | Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L |
| Change From Baseline to Week 48 in Actual Free 1,25-OHD | Baseline and wk 48 | Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L |
| Change From Baseline to Week 12 in 1,25-OHD | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in 1,25-OHD | Baseline and wk 24 | — |
| Change From Baseline to Week 48 in 1,25-OHD | Baseline and wk 48 | — |
| Change From Baseline to Week 12 in 25-OHD | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in 25-OHD | Baseline and wk 24 | — |
| Change From Baseline to Week 48 in 25-OHD | Baseline and wk 48 | — |
| Change From Baseline to Week 12 in TRP % | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in TRP % | Baseline and wk 24 | — |
| Change From Baseline to Week 48 in TRP % | Baseline and wk 48 | — |
| Change From Baseline to Week 12 in SPO4 | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in SPO4 | Baseline and wk 24 | — |
| Change From Baseline to Week 48 in SPO4 | Baseline and wk 48 | — |
| Change From Baseline to Week 12 in UCa/Ucr | Baseline and wk 12 | — |
| Change From Baseline to Week 24 in UCa/Ucr | Baseline and wk 24 | — |
| Change From Baseline to Week 48 in UCa/Ucr | Baseline and wk 48 | — |
| Change in Estimated GFR From Baseline to Week 12. | Baseline and wk 12 | To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group. eGFR calculated by the CKD-Epi equation for subjects \>=18 years of age, and by bedside Schwartz formula for subjects \<18 years of age |
| Change in Estimated GFR From Baseline to Week 24. | Baseline and wk 24 | To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group; |
| Change in Estimated GFR From Baseline to Week 48. | Baseline and wk 48 | To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group; |
| Change in UGluc From Baseline to Week 48 | Baseline and wk 48 | To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group; |
| Change in URBP/UCr Ratio From Baseline to Week 48 | Baseline and wk 48 | To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group; |
| Change in UB2MG From Baseline to Week 48 | Baseline and wk 48 | To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group; |
| Change in UProt/ UCr Ratio From Baseline to Week 48 | Baseline and wk 48 | To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group; |
| Change From Baseline to Week 12 in PTH | Baseline and wk 12 | — |
| 25-OHD Serum Concentration by Randomized Study Group at Week 24 | Week 24 | — |
| 25-OHD Serum Concentration by Randomized Study Group at Week 48 | Week 48 | — |
| Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use | Baseline | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use |
| Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use | Week 48 | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use |
| Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use | Baseline and wk 48 | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use |
| Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use | Baseline | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use |
| Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use | Week 48 | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use |
| Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use | Baseline and wk 48 | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use |
| 25-OHD Serum Concentration by Randomized Study Group at Week 12 | Week 12 | — |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
This research was conducted at 17 clinical sites, with accrual opening 10/2012. Due to budgetary constraints, accrual to protocol Version 1.0 was placed on hold 9/1/2013; follow-up visits for subjects on study continued while accrual was on hold. Version 2.0 opened to accrual on 2/2/2015. The study was closed to accrual on 6/3/1015.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Vitamin D3 50,000 IU Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily.
Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | 108 |
| Group B: Vitamin D3 Placebo Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily.
Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT | 104 |
| Total | 212 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Childcare issues | 1 | 1 |
| Overall Study | Fails to comply with study requirements | 0 | 1 |
| Overall Study | Inability to attend required visits | 0 | 1 |
| Overall Study | Inadvertent enrollment | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Missed 4 or more consecutive DOT visits | 2 | 3 |
| Overall Study | Moved out of the area | 1 | 5 |
| Overall Study | Off study due to multiple obligations | 0 | 1 |
| Overall Study | Starting hormone therapy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Group A: Vitamin D3 50,000 IU | Total | Group B: Vitamin D3 Placebo |
|---|---|---|---|
| Actual Free 125(OH)D | 418.48 fmol/L | 422.91 fmol/L | 445.29 fmol/L |
| Age, Continuous | 21.84 years STANDARD_DEVIATION 1.95 | 21.84 years STANDARD_DEVIATION 1.76 | 21.85 years STANDARD_DEVIATION 1.55 |
| Bone specific alkaline phosphatase (BAP) | 31.49 U/L | 31.62 U/L | 31.76 U/L |
| C-terminal telopeptides (CTX) | 0.76 mcg/L | 0.77 mcg/L | 0.78 mcg/L |
| Estimated glomerular filtration rate (eGFR) | 125.02 ml/min/1.73m^2 | 125.03 ml/min/1.73m^2 | 125.62 ml/min/1.73m^2 |
| Femoral neck BMD | 0.98 g/cm^2 | 0.99 g/cm^2 | 1.00 g/cm^2 |
| Femoral neck BMD (Z-score) | -0.50 Z-score | -0.60 Z-score | -0.60 Z-score |
| Fibroblast growth factor 23 (FGF23) | 33.23 pg/mL | 33.99 pg/mL | 34.53 pg/mL |
| Glucose Homeostasis (Fasting glucose) | 85.55 mg/dL | 85.68 mg/dL | 86.55 mg/dL |
| Glucose Homeostasis (Fasting insulin) | 8.87 uIU/mL | 8.70 uIU/mL | 8.69 uIU/mL |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 1.86 units on a scale | 1.85 units on a scale | 1.78 units on a scale |
| Lumbar spine BMD (L1-L4) (Z-score) | -0.65 z-score | -0.70 z-score | -0.70 z-score |
| Lumbar spine bone mineral density (BMD) | 1.06 g/cm^2 | 1.07 g/cm^2 | 1.08 g/cm^2 |
| Osteocalcin (OC) | 9.60 mcg/L | 9.21 mcg/L | 8.94 mcg/L |
| Parathyroid hormone (PTH) | 38.72 pg/mL | 37.73 pg/mL | 37.04 pg/mL |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 21 Participants | 45 Participants | 24 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic or Non-Latino | 87 Participants | 166 Participants | 79 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown/Not reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black | 78 Participants | 157 Participants | 79 Participants |
| Race/Ethnicity, Customized Race Non-black | 30 Participants | 55 Participants | 25 Participants |
| Season Enrolled Fall | 6 Participants | 11 Participants | 5 Participants |
| Season Enrolled Spring | 43 Participants | 85 Participants | 42 Participants |
| Season Enrolled Summer | 15 Participants | 33 Participants | 18 Participants |
| Season Enrolled Winter | 44 Participants | 83 Participants | 39 Participants |
| Serum 125 dihydroxy vitamin D (125-OHD) | 72.54 pg/mL | 71.08 pg/mL | 68.94 pg/mL |
| Serum Calcium (SCa) | 9.40 mg/dL | 9.39 mg/dL | 9.34 mg/dL |
| Serum Creatinine (SCr) | 0.89 mg/dL | 0.86 mg/dL | 0.86 mg/dL |
| Serum Phosphate (SPO4) | 3.56 mg/dL | 3.52 mg/dL | 3.50 mg/dL |
| Sex: Female, Male Female | 18 Participants | 33 Participants | 15 Participants |
| Sex: Female, Male Male | 90 Participants | 179 Participants | 89 Participants |
| Total Hip BMD | 1.06 g/cm^2 | 1.06 g/cm^2 | 1.05 g/cm^2 |
| Total hip BMD (Z-score) | -0.40 Z-score | -0.50 Z-score | -0.65 Z-score |
| Tubular reabsorption of phosphate (TRP) % | 91.72 percent | 91.56 percent | 91.53 percent |
| Urinary Calcium/ Urinary Creatinine ratio (UCa/UCr) | 0.04 ratio | 0.04 ratio | 0.04 ratio |
| Urine beta-2 microglobulin (UB2MG) | 111.17 mcg/L | 127.95 mcg/L | 134.08 mcg/L |
| Urine Glucose (UGluc) | 7.16 mg/dL | 7.27 mg/dL | 7.40 mg/dL |
| Urine protein (UProt) / Urine creatinine (UCr) | 0.07 ratio | 0.07 ratio | 0.07 ratio |
| Urine retinol binding protein (URBP)/ Urine creatinine (UCr) | 101.21 mcg/g | 101.21 mcg/g | 104.00 mcg/g |
| Vitamin D serum concentration (25-(OH)D Total) | 15.69 ng/mL | 16.37 ng/mL | 16.76 ng/mL |
| Whole Body BMD | 1.18 g/cm^2 | 1.17 g/cm^2 | 1.17 g/cm^2 |
| Whole body BMD (Z-score) | -0.60 Z-score | -0.70 Z-score | -0.80 Z-score |
| Whole Body Bone Mineral Content (BMC) | 2636.03 g | 2627.16 g | 2596.06 g |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 105 |
| other Total, other adverse events | 6 / 109 | 8 / 105 |
| serious Total, serious adverse events | 5 / 109 | 6 / 105 |
Outcome results
Primary
Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups
Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups. Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit.
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups | 0.19 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups | 0.09 percent change |
p-value: 0.1166Wilcoxon (Mann-Whitney)
Secondary
25-OHD Serum Concentration by Randomized Study Group at Week 12
Time frame: Week 12
Population: Subjects who had wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | 25-OHD Serum Concentration by Randomized Study Group at Week 12 | 35.14 ng/mL |
| Group B: Vitamin D3 Placebo | 25-OHD Serum Concentration by Randomized Study Group at Week 12 | 23.97 ng/mL |
Secondary
25-OHD Serum Concentration by Randomized Study Group at Week 24
Time frame: Week 24
Population: Subjects who had wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | 25-OHD Serum Concentration by Randomized Study Group at Week 24 | 37.04 ng/mL |
| Group B: Vitamin D3 Placebo | 25-OHD Serum Concentration by Randomized Study Group at Week 24 | 23.30 ng/mL |
Secondary
25-OHD Serum Concentration by Randomized Study Group at Week 48
Time frame: Week 48
Population: Subjects who had wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | 25-OHD Serum Concentration by Randomized Study Group at Week 48 | 36.89 ng/mL |
| Group B: Vitamin D3 Placebo | 25-OHD Serum Concentration by Randomized Study Group at Week 48 | 20.55 ng/mL |
Secondary
Change From Baseline to Week 12 in 1,25-OHD
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in 1,25-OHD | 15.61 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in 1,25-OHD | 6.06 pg/ML |
Secondary
Change From Baseline to Week 12 in 25-OHD
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in 25-OHD | 16.33 ng/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in 25-OHD | 6.91 ng/ML |
Secondary
Change From Baseline to Week 12 in Actual Free 1,25-OHD
Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in Actual Free 1,25-OHD | 106.50 fmol/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in Actual Free 1,25-OHD | 53.23 fmol/L |
Secondary
Change From Baseline to Week 12 in BAP
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in BAP | -1.05 U/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in BAP | -1.74 U/L |
Secondary
Change From Baseline to Week 12 in CTX
Time frame: Baseline and week 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in CTX | -0.03 mcg/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in CTX | -0.02 mcg/L |
Secondary
Change From Baseline to Week 12 in FGF23
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in FGF23 | 3.31 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in FGF23 | 3.90 pg/ML |
Secondary
Change From Baseline to Week 12 in OC
Time frame: Baseline and week 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in OC | 0.15 mcg/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in OC | -0.10 mcg/L |
Secondary
Change From Baseline to Week 12 in PTH
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in PTH | -2.17 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in PTH | -0.82 pg/ML |
Secondary
Change From Baseline to Week 12 in Serum Calcium (SCa)
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in Serum Calcium (SCa) | -0.02 mg/dL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in Serum Calcium (SCa) | 0.08 mg/dL |
Secondary
Change From Baseline to Week 12 in SPO4
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in SPO4 | 0.00 mg/dL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in SPO4 | 0.02 mg/dL |
Secondary
Change From Baseline to Week 12 in TRP %
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in TRP % | -0.71 percent |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in TRP % | 0.04 percent |
Secondary
Change From Baseline to Week 12 in UCa/Ucr
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 12 in UCa/Ucr | 0.00 ratio |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 12 in UCa/Ucr | 0.00 ratio |
Secondary
Change From Baseline to Week 24 in 1,25-OHD
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in 1,25-OHD | 12.90 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in 1,25-OHD | 8.58 pg/ML |
Secondary
Change From Baseline to Week 24 in 25-OHD
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in 25-OHD | 18.60 ng/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in 25-OHD | 6.78 ng/ML |
Secondary
Change From Baseline to Week 24 in Actual Free 1,25-OHD
Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in Actual Free 1,25-OHD | 98.61 fmol/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in Actual Free 1,25-OHD | 59.36 fmol/L |
Secondary
Change From Baseline to Week 24 in BAP
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in BAP | -2.54 U/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in BAP | -2.03 U/L |
Secondary
Change From Baseline to Week 24 in CTX
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in CTX | -0.03 mcg/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in CTX | -0.02 mcg/L |
Secondary
Change From Baseline to Week 24 in FGF23
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in FGF23 | 2.93 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in FGF23 | 3.65 pg/ML |
Secondary
Change From Baseline to Week 24 in OC
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in OC | 0.09 mcg/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in OC | -0.22 mcg/L |
Secondary
Change From Baseline to Week 24 in PTH
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in PTH | -0.25 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in PTH | -1.71 pg/ML |
Secondary
Change From Baseline to Week 24 in Serum Calcium (SCa)
Time frame: 24 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in Serum Calcium (SCa) | -0.04 mg/dL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in Serum Calcium (SCa) | 0.08 mg/dL |
Secondary
Change From Baseline to Week 24 in SPO4
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in SPO4 | -0.06 mg/dL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in SPO4 | 0.03 mg/dL |
Secondary
Change From Baseline to Week 24 in TRP %
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in TRP % | -0.59 percent |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in TRP % | -0.88 percent |
Secondary
Change From Baseline to Week 24 in UCa/Ucr
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 in UCa/Ucr | 0.01 ratio |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 in UCa/Ucr | 0.01 ratio |
Secondary
Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups | 0.00 z-score |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups | 0.00 z-score |
Secondary
Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | 0.00 z-score |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | 0.00 z-score |
Secondary
Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups | 0.00 z-score |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups | 0.00 z-score |
Secondary
Change From Baseline to Week 48 in 1,25-OHD
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in 1,25-OHD | 10.52 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in 1,25-OHD | 2.74 pg/ML |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.0144Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in 25-OHD
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in 25-OHD | 17.80 ng/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in 25-OHD | 2.64 ng/ML |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in Actual Free 1,25-OHD
Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in Actual Free 1,25-OHD | 63.73 fmol/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in Actual Free 1,25-OHD | 25.66 fmol/L |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.021Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in BAP
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in BAP | -2.71 U/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in BAP | -2.19 U/L |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.195Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in CTX
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in CTX | -0.08 mcg/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in CTX | -0.09 mcg/L |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.3728Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in FGF23
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in FGF23 | 4.77 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in FGF23 | 3.15 pg/ML |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.7127Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose) | 0.05 mg/dL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose) | -0.20 mg/dL |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.6499Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)
Time frame: Baseline and 48 weeks
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin) | 0.45 uIU/mL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin) | -0.83 uIU/mL |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.255Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))
HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of \>2 for any insulin resistance, but normal values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance).
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)) | 0.07 units on a scale |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)) | -0.15 units on a scale |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.2348Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in OC
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in OC | -0.93 mcg/L |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in OC | -0.48 mcg/L |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.7825Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in PTH
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in PTH | -2.21 pg/ML |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in PTH | -0.96 pg/ML |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.4676Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in Serum Calcium (SCa)
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in Serum Calcium (SCa) | 0.00 mg/dL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in Serum Calcium (SCa) | 0.04 mg/dL |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.2648Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in SPO4
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in SPO4 | -0.03 mg/dL |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in SPO4 | -0.12 mg/dL |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.4808Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in TRP %
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in TRP % | -1.55 percent |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in TRP % | 0.62 percent |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.0814Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 in UCa/Ucr
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 in UCa/Ucr | 0.00 ratio |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 in UCa/Ucr | 0.01 ratio |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.387Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups | 0.00 z-score |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups | 0.00 z-score |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.7601Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | 0.00 z-score |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | -0.10 z-score |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.1378Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups | 0.00 z-score |
| Group B: Vitamin D3 Placebo | Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups | 0.00 z-score |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.1187Wilcoxon (Mann-Whitney)
Secondary
Change in Estimated GFR From Baseline to Week 12.
To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group. eGFR calculated by the CKD-Epi equation for subjects \>=18 years of age, and by bedside Schwartz formula for subjects \<18 years of age
Time frame: Baseline and wk 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in Estimated GFR From Baseline to Week 12. | 0.00 ml/min/1.73m^2 |
| Group B: Vitamin D3 Placebo | Change in Estimated GFR From Baseline to Week 12. | 0.00 ml/min/1.73m^2 |
Secondary
Change in Estimated GFR From Baseline to Week 24.
To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group;
Time frame: Baseline and wk 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in Estimated GFR From Baseline to Week 24. | 0.00 ml/min/1.73m^2 |
| Group B: Vitamin D3 Placebo | Change in Estimated GFR From Baseline to Week 24. | 0.00 ml/min/1.73m^2 |
Secondary
Change in Estimated GFR From Baseline to Week 48.
To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group;
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in Estimated GFR From Baseline to Week 48. | -1.91 ml/min/1.73m^2 |
| Group B: Vitamin D3 Placebo | Change in Estimated GFR From Baseline to Week 48. | 0.00 ml/min/1.73m^2 |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.429Wilcoxon (Mann-Whitney)
Secondary
Change in SCr From Baseline to Week 12.
To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group;
Time frame: Baseline and week 12
Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in SCr From Baseline to Week 12. | 0.03 mg/dL |
| Group B: Vitamin D3 Placebo | Change in SCr From Baseline to Week 12. | 0.02 mg/dL |
Secondary
Change in SCr From Baseline to Week 24.
To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group;
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in SCr From Baseline to Week 24. | 0.02 mg/dL |
| Group B: Vitamin D3 Placebo | Change in SCr From Baseline to Week 24. | 0.02 mg/dL |
Secondary
Change in SCr From Baseline to Week 48.
To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group;
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in SCr From Baseline to Week 48. | 0.03 mg/dL |
| Group B: Vitamin D3 Placebo | Change in SCr From Baseline to Week 48. | 0.01 mg/dL |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.5098Wilcoxon (Mann-Whitney)
Secondary
Change in UB2MG From Baseline to Week 48
To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group;
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in UB2MG From Baseline to Week 48 | 5.19 mcg/L |
| Group B: Vitamin D3 Placebo | Change in UB2MG From Baseline to Week 48 | 10.75 mcg/L |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.581Wilcoxon (Mann-Whitney)
Secondary
Change in UGluc From Baseline to Week 48
To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group;
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in UGluc From Baseline to Week 48 | -0.42 mg/dL |
| Group B: Vitamin D3 Placebo | Change in UGluc From Baseline to Week 48 | -0.43 mg/dL |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.9186Wilcoxon (Mann-Whitney)
Secondary
Change in UProt/ UCr Ratio From Baseline to Week 48
To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group;
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in UProt/ UCr Ratio From Baseline to Week 48 | 0.00 ratio |
| Group B: Vitamin D3 Placebo | Change in UProt/ UCr Ratio From Baseline to Week 48 | 0.00 ratio |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.157Wilcoxon (Mann-Whitney)
Secondary
Change in URBP/UCr Ratio From Baseline to Week 48
To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group;
Time frame: Baseline and wk 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Change in URBP/UCr Ratio From Baseline to Week 48 | -1.06 mcg/g |
| Group B: Vitamin D3 Placebo | Change in URBP/UCr Ratio From Baseline to Week 48 | -4.72 mcg/g |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)p-value: 0.4016Wilcoxon (Mann-Whitney)
Secondary
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use
Time frame: Baseline and wk 48
Population: Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vitamin D3 50,000 IU | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use | 10.97 ng/mL | Standard Deviation 12 |
| Group B: Vitamin D3 Placebo | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use | 9.79 ng/mL | Standard Deviation 11.68 |
Comparison: Test of change from baseline to week 48p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Test of change from baseline to Week 48p-value: <0.0001Wilcoxon Signed Rank Test
Secondary
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use
Time frame: Baseline
Population: Authors were interested in comparing mean 25-OHD at baseline by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vitamin D3 50,000 IU | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use | 17.02 ng/mL | Standard Deviation 8.69 |
| Group B: Vitamin D3 Placebo | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use | 19.61 ng/mL | Standard Deviation 9.96 |
Secondary
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use
Time frame: Week 48
Population: Authors were interested in comparing mean 25-OHD at wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vitamin D3 50,000 IU | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use | 28.24 ng/mL | Standard Deviation 11.22 |
| Group B: Vitamin D3 Placebo | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use | 29.68 ng/mL | Standard Deviation 11.52 |
Secondary
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use
Time frame: Baseline and wk 48
Population: Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vitamin D3 50,000 IU | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use | 10.55 ng/mL | Standard Deviation 11.07 |
| Group B: Vitamin D3 Placebo | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use | 10.02 ng/mL | Standard Deviation 12.28 |
Comparison: Test of Week 48 difference from baselinep-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Test of Week 48 difference from baselinep-value: <0.0001Wilcoxon Signed Rank Test
Secondary
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use
Time frame: Baseline
Population: Authors were interested in comparing mean 25-OHD at baseline by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vitamin D3 50,000 IU | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use | 18.62 ng/mL | Standard Deviation 8.79 |
| Group B: Vitamin D3 Placebo | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use | 18.69 ng/mL | Standard Deviation 10.13 |
Secondary
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use
Time frame: Week 48
Population: Authors were interested in comparing mean 25-OHD at wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vitamin D3 50,000 IU | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use | 29.46 ng/mL | Standard Deviation 10.7 |
| Group B: Vitamin D3 Placebo | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use | 28.92 ng/mL | Standard Deviation 11.89 |
Secondary
Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups | 0.25 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups | 0.07 percent change |
Secondary
Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups | -0.10 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups | -0.04 percent change |
Secondary
Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups | 0.94 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups | 0.42 percent change |
Secondary
Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups
Time frame: Baseline and week 24
Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups | -0.27 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups | 0.00 percent change |
Secondary
Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups | 0.08 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups | 0.07 percent change |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.8383Wilcoxon (Mann-Whitney)
Secondary
Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups | -0.30 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups | -0.11 percent change |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.4686Wilcoxon (Mann-Whitney)
Secondary
Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups
Time frame: Baseline and week 48
Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: Vitamin D3 50,000 IU | Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups | -0.17 percent change |
| Group B: Vitamin D3 Placebo | Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups | -0.42 percent change |
Comparison: Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)p-value: 0.3978Wilcoxon (Mann-Whitney)