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NCT00427037 · ClinicalTrials.gov registry record · NA
Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects
A NA study of Chronic Kidney Disease and Vitamin D Deficiency, sponsored by Atlanta VA Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT00427037 is a NA study of Chronic Kidney Disease and Vitamin D Deficiency that has completed, run by Atlanta VA Medical Center. The registered enrollment target is 34 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00427037, a NA study of Chronic Kidney Disease and Vitamin D Deficiency, has completed, sponsored by Atlanta VA Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of the subjects will be randomized to vitamin D3 and the other half will receive a placebo. Subjects will be referred from the nutrition or renal clinic at Emory. CKD stage 3 and 4 patients will be eligible for participation if they have been determined to have vitamin D deficiency and are not on treatment with vitamin D or vitamin D analogues. Subjects will sign an informed consent form after reviewing the protocol in detail with the principal investigator. A questionnaire would collect information about dietary vitamin D intake, sunlight exposure, and any symptoms of vitamin D deficiency. The subject will have baseline levels of serum vitamin D (25-hydroxyvitamin D), parathyroid hormone (PTH), serum calcium and phosphate, creatinine and other markers of bone turnover. The questionnaires and the blood draws would be repeated on the 6th and 12th week of the study. Subjects will be given 12 pills of each containing either 50,000 IU vitamin D or placebo and asked to take one pill a week. They would be scheduled to return to the clinic after 6 weeks and blood measurements would be repeated. Subjects will be asked to revisit for their final visit at the 12th week when they would have their last blood draw and assessment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cholecalciferol
Study Locations (1)
Georgia
- Emory Clinic - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2005-12 |
| Est. Completion | 2013-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00427037
The ClinicalTrials.gov registry entry for NCT00427037 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower). The listed sponsor is Atlanta VA Medical Center, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00427037 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT00427037 about?
NCT00427037 is a clinical study titled "Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects". This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of the subjects will be randomized to vitamin D3 and the other half will receive a placebo. Subjects will be referred from the nutrition or renal clinic at Emory. CKD stage 3 and 4 patients will be eligible fo...
What is the current status of trial NCT00427037?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2005-12. Estimated completion is 2013-03.
What conditions does trial NCT00427037 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Vitamin D Deficiency.
What interventions are being tested in trial NCT00427037?
The interventions under investigation include: Placebo (DRUG), Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT00427037?
This trial is sponsored by Atlanta VA Medical Center, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00427037 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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