Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease - Full Text View

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:	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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetic Kidney Problems Kidney Failure Urine and Urination Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

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
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

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 H. de Boer, MD MS, 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
Last Updated:	July 8, 2011
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
Kidney Failure, Chronic
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 February 09, 2012