Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Diabetes Mellitus Clinical Trial

Official title:

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic

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