Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Diabetes Mellitus, Chronic Kidney Disease, Diabetic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT00552409
- Run by
- University of Washington
- People needed
- 22
- Starts
- 2007-12-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2014-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Incontinent of urine
- Failure to take greater than or equal to 80% of placebo pills during study run-in
Where it is running
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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