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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00552409
Other study ID # 31615-D
Secondary ID 1KL2RR025015-015
Status Completed
Phase Phase 2/Phase 3
First received October 31, 2007
Last updated April 9, 2014
Start date December 2007
Est. completion date June 2010

Study information

Verified date April 2014
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Dietary Supplement:
Cholecalciferol
2000 IU by mouth daily for one year
Placebo
One softgel daily for one year

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington University of Washington Institute for Translational Health Science (KL2)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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