Clinical trial NCT01029002: The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
Official title: The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Renal Insufficiency
Proteinuria
Keywords: Vitamin D
CKD
proteinuria
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-12-09
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
measure: Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome.
timeFrame: 3 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore medical center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Michal Melamed, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: