Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00749736 · ClinicalTrials.gov registry record · Phase 4
The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT00749736 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 100 participants.
The verdict
NCT00749736, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D). Patients with CKD are also known to have abnormalities in their immune cells, increased susceptibility to infection and increased prevalence of malignancies. In patients without kidney disease, repletion of vitamin D appears to help some immune mediated diseases. Thus it is logical that patients with CKD who are vitamin D deficient may benefit from repletion of vitamin D, in either its native form (cholecalciferol/ergocalciferol) or in the form of calcitriol or its analogues. However, no interventional data demonstrates that repletion positively impacts immune status in CKD patients. To test this hypothesis, a large interventional study will be required. However, prior to conducting this study, several important steps are needed. The present proposal aims to generate the necessary data to appropriately plan and conduct a future multi center interventional study. Specifically, we will examine the following specific aims in a population of CKD stage 3 and 4 subjects from Indiana University Affiliated Nephrology Clinics and determine 1. if abnormalities in immune cells and immune blood tests are related to abnormalities in vitamin D. 2. how reproducible these changes are on repeat testing and 3. if repletion of vitamin D changes these cells and immune blood tests in a small pilot study.
Interventions
- DIETARY_SUPPLEMENT placebo
- DIETARY_SUPPLEMENT cholecalciferol
- DIETARY_SUPPLEMENT doxercalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00749736
The ClinicalTrials.gov registry entry for NCT00749736 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00749736 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00749736 about?
NCT00749736 is a clinical study titled "The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.". Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D). Patients with CKD are also known to have abnormalities in their immune cells, increased susceptibility to infection and in...
What is the current status of trial NCT00749736?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2008-07. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00749736?
The interventions under investigation include: placebo (DIETARY_SUPPLEMENT), cholecalciferol (DIETARY_SUPPLEMENT), doxercalciferol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00749736?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.