Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
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Study type
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
- Incontinent of urine
- Failure to take greater than or equal to 80% of placebo pills during study run-in
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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