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

Tracking Information

First Received Date ^ICMJE

October 31, 2007

Last Updated Date

September 28, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in urine albumin excretion [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in urine albumin excretion [ Time Frame: One year ]

Change History

Complete list of historical versions of study NCT00552409 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Change in serum calcium concentration [ Time Frame: 3 months - 1 year ]
Change in serum 25-hydroxyvitamin D concentration [ Time Frame: 3 months - 1 year ]
Change in 24-hour ambulatory blood pressure [ Time Frame: 3 months - 1 year ]
Change in plasma lipids and lipoproteins [ Time Frame: 3 months - 1 year ]
Change in circulating inflammatory proteins [ Time Frame: 3 months - 1 year ]
Changes in circulating markers of mineral metabolism and insulin sensitivity [ Time Frame: 3 months - 1 year ]

Descriptive Information

Brief Title ^ICMJE

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Official Title ^ICMJE

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Brief Summary

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Condition ^ICMJE

Diabetes Mellitus
Chronic Kidney Disease
Diabetic Kidney Disease

Intervention ^ICMJE

Dietary Supplement: Cholecalciferol
Dietary Supplement: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ian H de Boer, MD, MS

(206) 616-5403

deboer@u.washington.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00552409

Responsible Party

Ian H. de Boer, MD MS, Principal Investigator, University of Washington

Study ID Numbers ^ICMJE

31615-D, 1KL2RR025015-01;, 5 P30 DK17047;, 07-5221-A 01

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

University of Washington Institute for Translational Health Science (KL2)

Investigators ^ICMJE

Principal Investigator:

Ian H de Boer, MD, MS

University of Washington

Information Provided By

University of Washington

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP