NCT00552409

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Chronic Kidney Disease
• Diabetic Kidney Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	2000 IU by mouth daily for one year
DIETARY_SUPPLEMENT	Placebo	One softgel daily for one year

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-11-01
• Last updated: 2014-04-28
• Results posted: 2013-09-27

Locations

1 site across 1 country: United States