Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
4 other identifiers
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus
Started Dec 2007
Typical duration for phase_2 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2007
CompletedFirst Posted
Study publicly available on registry
November 1, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
September 27, 2013
CompletedApril 28, 2014
April 1, 2014
2.5 years
October 31, 2007
June 18, 2013
April 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Urine Albumin Excretion
Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.
Baseline, 3 months, and one year
Study Arms (2)
Cholecalciferol
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
- hydroxyvitamin D less than 30 ng/mL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 33184642DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ian de Boer
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Ian H de Boer, MD, MS
University of Washington
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
October 31, 2007
First Posted
November 1, 2007
Study Start
December 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
April 28, 2014
Results First Posted
September 27, 2013
Record last verified: 2014-04