Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- University of Washington
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change in Urine Albumin Excretion
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease and cardiovascular risk among people with diabetes mellitus and early kidney disease. Eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60 mL/min. Participants will be randomly assigned to treatment with vitamin D3 or placebo, each taken by mouth once daily for a study duration of one year. Study medications will be added to standard treatment, including an angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker. We hypothesize that vitamin D3, compared with placebo: (1) is well-tolerated and safe among people with diabetes and kidney disease; (2) results in adequate attained circulating vitamin D levels; and (3) positively affects markers of kidney disease and cardiovascular risk.
Investigators
Ian deBoer
Study Principal Investigator
University of Washington
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of type 2 diabetes mellitus
- •Urine albumin-creatinine ratio 30-1000 mg/g
- •Estimated glomerular filtration rate greater than or equal to 60 mL/min
- •Treatment with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker for greater than or equal to 6 months, with a stable dose for greater than or equal to 3 months
- •Blood pressure less than 140/90 (assessed while taking medications)
- •Hemoglobin A1c less than 9% (assessed while taking medications)
- •25-hydroxyvitamin D less than 30 ng/mL
Exclusion Criteria
- •Prior dialysis or kidney transplantation
- •Known cause of albuminuria other than diabetes
- •Planning to leave the area within 12 months
- •Life expectancy less than 12 months
- •Participation in another clinical trial within 6 months
- •Osteoporosis or other established indication for vitamin D therapy
- •Vitamin D3 supplement intake greater than 400 IU/day at screening visit
- •History of nephrolithiasis
- •Serum calcium greater than 10.2 mg/dL
- •Dementia, not fluent in English, or unable to provide informed consent without proxy respondent
Outcomes
Primary Outcomes
Change in Urine Albumin Excretion
Time Frame: Baseline, 3 months, and one year
Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.