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Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
This study is currently recruiting participants.
Verified by University of Washington, September 2009
First Received: October 31, 2007   Last Updated: September 28, 2009   History of Changes
Sponsor: University of Washington
Collaborator: University of Washington Institute for Translational Health Science (KL2)
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00552409
  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 II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum calcium concentration [ Time Frame: 3 months - 1 year ] [ Designated as safety issue: Yes ]
  • Change in serum 25-hydroxyvitamin D concentration [ Time Frame: 3 months - 1 year ] [ Designated as safety issue: No ]
  • Change in 24-hour ambulatory blood pressure [ Time Frame: 3 months - 1 year ] [ Designated as safety issue: No ]
  • Change in plasma lipids and lipoproteins [ Time Frame: 3 months - 1 year ] [ Designated as safety issue: No ]
  • Change in circulating inflammatory proteins [ Time Frame: 3 months - 1 year ] [ Designated as safety issue: No ]
  • Changes in circulating markers of mineral metabolism and insulin sensitivity [ Time Frame: 3 months - 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cholecalciferol: Experimental Dietary Supplement: Cholecalciferol
2000 IU by mouth daily for one year
Placebo: Placebo Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552409

Contacts
Contact: Ian H de Boer, MD, MS (206) 616-5403 deboer@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Alexandra Flynn     206-221-3938     af25@u.washington.edu    
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: University of Washington ( Ian H. de Boer, MD MS, Principal Investigator )
Study ID Numbers: 31615-D, 1KL2RR025015-01;, 5 P30 DK17047;, 07-5221-A 01
Study First Received: October 31, 2007
Last Updated: September 28, 2009
ClinicalTrials.gov Identifier: NCT00552409     History of Changes
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:
Cholecalciferol
Renal Insufficiency
Diabetic Nephropathies
Metabolic Diseases
Growth Substances
Physiological Effects of Drugs
Diabetes Mellitus
Kidney Failure, Chronic
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Vitamin D
Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Micronutrients
Kidney Diseases
Glucose Metabolism Disorders
Diabetes Complications
Kidney Failure

ClinicalTrials.gov processed this record on November 27, 2009