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Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
This study is ongoing, but not recruiting participants. First
Received: October 31, 2007 Last Updated: December 2, 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:
MedlinePlus related topics: Diabetes Diabetic Kidney Problems Dietary
Supplements Diets Urine and Urination 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

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

Locations

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

Sponsors and CollaboratorsUniversity of WashingtonUniversity 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:

December 2, 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 March 01, 2010

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