Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
NCT ID: NCT00552409
Last Updated: 2014-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
22 participants
INTERVENTIONAL
2007-12-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cholecalciferol
Cholecalciferol
2000 IU by mouth daily for one year
Placebo
Placebo
One softgel daily for one year
Interventions
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Cholecalciferol
2000 IU by mouth daily for one year
Placebo
One softgel daily for one year
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Washington Institute for Translational Health Science (KL2)
OTHER
University of Washington
OTHER
Responsible Party
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Ian deBoer
Study Principal Investigator
Principal Investigators
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Ian H de Boer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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Best CM, Riley DV, Laha TJ, Pflaum H, Zelnick LR, Hsu S, Thummel KE, Foster-Schubert KE, Kuzma JN, Cromer G, Larson I, Hagman DK, Heshelman K, Kratz M, de Boer IH, Hoofnagle AN. Vitamin D in human serum and adipose tissue after supplementation. Am J Clin Nutr. 2021 Jan 4;113(1):83-91. doi: 10.1093/ajcn/nqaa295.
Other Identifiers
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