At a glance
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Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
In Brief
A Phase 3 clinical trial evaluating Cholecalciferol and Placebo for Diabetes Mellitus and 2 related conditions. Completed, enrolled 22 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
2000 IU by mouth daily for one year
One softgel daily for one year