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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: Completed Phase 4 study, sponsored by Indiana University.
NCT00749736 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00749736 record still lists
NCT00749736 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00749736 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00749736's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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