Chronic Renal Insufficiency, Proteinuria
Conditions
Keywords
Vitamin D, CKD, proteinuria
Brief summary
A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.
Detailed description
This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals. Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives. Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months. There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months. Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
Interventions
DRUGVitamin D
Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months
OTHERPlacebo
Patients randomized to this arm will receive one placebo pill once weekly.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Ability to provide informed consent * Chronic kidney disease stage 3 and 4 * On ACE inhibitor or ARB for albuminuria if tolerated * Assessed during eligibility screen: * Albuminuria \>30 mg/g creatinine * 25(OH) vitamin D level \>12.5 and \<75 nmol/L
Exclusion criteria
* On vitamin D in past 4 weeks * Plans to relocate out of New York City in the next 6 months * 25 (OH) Vitamin D level \<12.5 nmol/L * HIV infection * History of hypercalcemia or kidney stones * Serum phosphate \>5.5 mg/dl in past 3 months * Serum calcium \>10.0 mg/dl in past 3 months * SBP \>160 DBP \>100 at screening visit * Transplanted organ * Cancer * Polycystic kidney disease * Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. | 3 months | Urine albumin and creatinine were measured on spot urine specimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome. | 3 months | 25(OH) vitamin D levels were measured using liquid chromatography. |
| Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome. | 3 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D 50000 IU Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly.
Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months | 36 |
| Placebo Patients randomized to this arm will receive a placebo pill once weekly.
Placebo: Patients randomized to this arm will receive one placebo pill once weekly. | 38 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | Vitamin D 50000 IU | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 9.9 | 55.3 years STANDARD_DEVIATION 14.3 | 57.9 years STANDARD_DEVIATION 12.6 |
| Race/Ethnicity, Customized Hispanic | 17 Participants | 19 Participants | 36 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 13 Participants | 15 Participants | 28 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 36 Participants | 38 Participants | 74 Participants |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 32 Participants |
| Sex: Female, Male Male | 18 Participants | 24 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 38 |
| other Total, other adverse events | 0 / 36 | 0 / 38 |
| serious Total, serious adverse events | 12 / 36 | 17 / 38 |
Outcome results
Primary
Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.
Urine albumin and creatinine were measured on spot urine specimens.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D 50000 IU | Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. | 1126.68 mg/gram creatinine | Standard Deviation 1505.26 |
| Placebo | Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. | 1061.39 mg/gram creatinine | Standard Deviation 1354.71 |
Secondary
Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome.
25(OH) vitamin D levels were measured using liquid chromatography.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D 50000 IU | Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome. | 29.9 ng/mL | Standard Deviation 13.8 |
| Placebo | Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome. | 17.1 ng/mL | Standard Deviation 7.9 |
Secondary
Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome.
Time frame: 3 months
Population: Ambulatory pressure data readings were not collected and therefore data was not able to be aggregated and analyzed.