The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Endocrine, Nephrology |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/25/2018 |
| Start Date: | October 2009 |
| End Date: | June 2014 |
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.
Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney
damage.
This RCT will enroll 75 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.
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.
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
We found this trial at
1
site
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
