Randomized Controlled Trial of Vitamin D3 in Diabetic K...

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
This study is currently recruiting participants.
Verified by University of Washington, August 2008
Sponsors and Collaborators: University of Washington
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 ¡Ý 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

MedlinePlus related topics: Diabetes Diabetic Kidney Problems Dietary Supplements Urine and Urination
Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol
U.S. FDA Resources
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

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:September 2009
Estimated Primary Completion Date:September 2009 (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 30-300 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)
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

Responsible Party:University of Washington ( Ian H. de Boer, MD MS, Principal Investigator )
Study ID Numbers:07-5221-A 01, 1KL2RR025015-01, 5 P30 DK17047
First Received:October 31, 2007
Last Updated:August 15, 2008
ClinicalTrials.gov Identifier:NCT00552409 [history]
Health Authority:United States: Institutional Review Board

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

Study placed in the following topic categories:
Cholecalciferol
Renal Insufficiency
Diabetic Nephropathies
Albuminuria
Metabolic Diseases
Ergocalciferols
Kidney Failure, Chronic
Diabetes Mellitus
Endocrine System Diseases
Vitamin D
Urologic Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications
Kidney Failure

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions