Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
University of Washington Institute for Translational Health Science (KL2)
Information provided by (Responsible Party):
Ian deBoer, University of Washington
ClinicalTrials.gov Identifier:
NCT00552409
First received: October 31, 2007
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Chronic Kidney Disease
Diabetic Kidney Disease
Dietary Supplement: Cholecalciferol
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in Urine Albumin Excretion [ Time Frame: Baseline, 3 months, and one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: December 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol Dietary Supplement: Cholecalciferol
2000 IU by mouth daily for one year
Placebo Comparator: Placebo Dietary Supplement: Placebo
One softgel daily for one year

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552409

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
University of Washington Institute for Translational Health Science (KL2)
Investigators
Principal Investigator: Ian H de Boer, MD, MS University of Washington
  More Information

No publications provided

Responsible Party: Ian deBoer, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00552409     History of Changes
Other Study ID Numbers: 31615-D, 1KL2RR025015-01;, 5 P30 DK17047;, 07-5221-A 01
Study First Received: October 31, 2007
Results First Received: June 18, 2013
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Diabetes mellitus
Type 2 diabetes
Chronic kidney disease
Diabetic kidney disease
Microalbuminuria
Albuminuria
Vitamin D
Cholecalciferol
Kidney
Renal
Cardiovascular
Clinical trial
Placebo

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Nephropathies
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Renal Insufficiency
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014