ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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 ≥ 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   

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    
  More Information


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
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

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

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers