The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

Study Overview
=================
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.

Official Title
-----------------
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

Conditions
-----------------
Chronic Renal Insufficiency, Proteinuria

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D 50000 IU<br>Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. | Drug: Vitamin D<br>* Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months<br>|
| Placebo Comparator: Placebo<br>Patients randomized to this arm will receive a placebo pill once weekly. | Other: Placebo<br>* Patients randomized to this arm will receive one placebo pill once weekly.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, Vitamin D, proteinuria