Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
This study has been completed.
Sponsor:
University of Washington
Collaborator:
University of Washington Institute for Translational Health Science (KL2)
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00552409
First received: October 31, 2007
Last updated: July 8, 2011
Last verified: July 2011
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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 2 Phase 3 |
| 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:
MedlinePlus related topics:
Chronic Kidney Disease
Diabetes
Diabetic Kidney Problems
Urine and Urination
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 Renal Insufficiency, Chronic Kidney Failure, 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 June 18, 2013