Expired Study
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Seattle, Washington 98195


Purpose:

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.


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 - Incontinent of urine - Failure to take greater than or equal to 80% of placebo pills during study run-in


NCT ID:

NCT00552409


Primary Contact:

Principal Investigator
Ian H de Boer, MD, MS
University of Washington


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98195
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 16, 2017

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