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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 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.

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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.

Conditions Studied

Diabetes Mellitus Chronic Kidney Disease Diabetic Kidney Disease

Interventions

  • DIETARY_SUPPLEMENT Cholecalciferol
  • DIETARY_SUPPLEMENT Placebo

Study Locations (1)

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2007-12
Est. Completion 2010-06
Phase Phase 2

Sponsor

University of Washington

1,048 total trials

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What the Registry Record Tells You About NCT00552409

The ClinicalTrials.gov registry entry for NCT00552409 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.