HIV Infections
Conditions
Keywords
HIV, Vitamin D Deficiency
Brief summary
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
Detailed description
The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.
Interventions
DRUGVitamin D control dose
18,000 IU per month
DRUGVitamin D supplementation-
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Sponsors
Emory University
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 8-25 * Documented HIV-1 infection * On stable antiretroviral therapy for \> 3 months * Cumulative antiretroviral therapy of at least 6 months * 25(OH)D level \< 30 ng/ml at screening
Exclusion criteria
* \> 400 IU daily regular vitamin D intake * Parathyroid/calcium disorders * Active malignancy * Pregnancy/intent to become pregnant/breastfeeding * Chronic infectious/inflammatory conditions * Creatinine clearance \< 50 ml/min * Hemoglobin \< 9.0 g/dL * Aspartate aminotransferase and alanine aminotransferase \> 2.5 upper limit of normal * Diabetes requiring hypoglycemic agents * Known coronary artery disease * Inability to swallow pills
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Serum 25(OH)D3 Levels | 6 months | Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Vitamin D Binding Protein (VDBP) | 6 months | Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV+ With Vit D Supplementation HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose | 66 |
| HIV+ Young Adults With Vitamin D Control Dose HIV+ receiving Vitamin D low dose: 18,000 IU per month | 36 |
| HIV - With Vitamin D Supplementation HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month. | 58 |
| HIV - With Vitamin D Control Dose HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month | 30 |
| Total | 190 |
Baseline characteristics
| Characteristic | HIV+ With Vit D Supplementation | HIV - With Vitamin D Control Dose | HIV - With Vitamin D Supplementation | Total | HIV+ Young Adults With Vitamin D Control Dose |
|---|---|---|---|---|---|
| Age, Continuous | 20.9 years | 18.4 years | 19.6 years | 19.9 years | 19.9 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants | 29 Participants | 47 Participants | 167 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 1 Participants | 11 Participants | 23 Participants | 2 Participants |
| Region of Enrollment United States | 66 participants | 30 participants | 58 participants | 190 participants | 36 participants |
| Sex: Female, Male Female | 22 Participants | 15 Participants | 20 Participants | 72 Participants | 15 Participants |
| Sex: Female, Male Male | 44 Participants | 15 Participants | 38 Participants | 118 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 66 | 0 / 58 | 0 / 30 |
| other Total, other adverse events | 0 / 36 | 0 / 66 | 0 / 30 | 0 / 58 |
| serious Total, serious adverse events | 0 / 36 | 0 / 66 | 0 / 30 | 0 / 58 |
Outcome results
Primary
Changes in Serum 25(OH)D3 Levels
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )
Time frame: 6 months
Population: HIV-infected on vitamin D control or supplementation dose and matched HIV-uninfected group on control or supplementation dose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Positive on Vit D Control Dose | Changes in Serum 25(OH)D3 Levels | 11 ng/mL |
| HIV Positive on Vit D Supplementation Dose | Changes in Serum 25(OH)D3 Levels | 22 ng/mL |
| HIV Negative on Vitamin D Control Dose | Changes in Serum 25(OH)D3 Levels | 7.5 ng/mL |
| HIV Negative on Vitamin D Supplementation Dose | Changes in Serum 25(OH)D3 Levels | 25 ng/mL |
Secondary
Changes in Vitamin D Binding Protein (VDBP)
Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.
Time frame: 6 months
Population: HIV-infected children and young adults and matched healthy control group. Results were not analyzed were captured comparing HIV+ young adults on control or supplementation vit D to HIV - controls
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HIV Positive on Vit D Control Dose | Changes in Vitamin D Binding Protein (VDBP) | 3.9 ng/mL |
| HIV Positive on Vit D Supplementation Dose | Changes in Vitamin D Binding Protein (VDBP) | -8.9 ng/mL |
| HIV Negative on Vitamin D Control Dose | Changes in Vitamin D Binding Protein (VDBP) | -11.3 ng/mL |
| HIV Negative on Vitamin D Supplementation Dose | Changes in Vitamin D Binding Protein (VDBP) | -11.7 ng/mL |