Phase 3 N=22 Randomized Quadruple-blind Treatment

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Diabetes Mellitus · Chronic Kidney Disease · Diabetic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT00552409 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcome: Primary: Change in Urine Albumin Excretion — -21; -5 percent difference

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Cholecalciferol (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Urine Albumin Excretion	-21; -5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00552409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.