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NCT00552409 · ClinicalTrials.gov registry record · Phase 2
Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
A Phase 2 study of Diabetes Mellitus and Chronic Kidney Disease, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT00552409: Completed Phase 2 study of Diabetes Mellitus and Chronic Kidney Disease, sponsored by University of Washington.
NCT00552409 is a Phase 2 study of Diabetes Mellitus and Chronic Kidney Disease that has completed, run by University of Washington. The registered enrollment target is 22 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00552409, a Phase 2 study of Diabetes Mellitus and Chronic Kidney Disease, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Cholecalciferol
- DIETARY_SUPPLEMENT Placebo
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00552409 record still lists
NCT00552409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Cholecalciferol is the first listed.
NCT00552409 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT00552409 about?
NCT00552409 is a clinical study titled "Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease". 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 ty...
What is the current status of trial NCT00552409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2007-12. Estimated completion is 2010-06.
What conditions does trial NCT00552409 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Chronic Kidney Disease, Diabetic Kidney Disease.
What interventions are being tested in trial NCT00552409?
The interventions under investigation include: Cholecalciferol (DIETARY_SUPPLEMENT), Placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00552409?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00552409 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00552409's enrollment target sits among peer trials
22 192nd of 208 higher than 16 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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