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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01029002
Other study ID # 2007-266
Secondary ID K23DK078774
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2009
Est. completion date June 2014

Study information

Verified date August 2023
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Vitamin D
Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months
Other:
Placebo
Patients randomized to this arm will receive one placebo pill once weekly.

Locations

Country Name City State
United States Montefiore medical center Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Albert Einstein College of Medicine National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 3 months
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. 3 months
Secondary 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
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