Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01911169 · ClinicalTrials.gov registry record · Phase 2
Vitamin D to Improve Endothelial Function in SLE
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01911169 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 9 participants.
The verdict
NCT01911169, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Determine the effect of vitamin D repletion on flow mediated dilation (FMD, a measure of endothelial function) in vitamin D deficient systemic lupus erythematosus (SLE) patients. The investigators will enroll vitamin D deficient SLE patients and randomize them to receive either 400 IU or 5,000 IU of cholecalciferol (D3) daily and measure change in FMD as a measure of EC function at baseline and after 16 weeks of repletion. Determine mechanisms by which vitamin D repletion may improve endothelial function in vitamin D deficient SLE patients and in vitro. Determine effect of oral D3 repletion on the Type I interferon signature in WISH and ECs cultured with pre and post plasma from D3 treated lupus patients. Determine effect of D3 repletion on the number of circulating apoptotic and non-apoptotic EC and EPC ex vivo. Determine effect of exogenous 1,25(OH)D on IFN gene signature in WISH and ECs stimulated by pretreatment SLE plasma in vitro. Determine the effects of exogenous 1,25(OH)D on the phenotype of ECs cultured with pretreatment lupus plasma. This study is designed to efficiently test our hypothesis and begin to define interferon-dependent pathways through which vitamin D repletion can restore clinical and in vitro endothelial function.
Interventions
- DRUG Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01911169
The ClinicalTrials.gov registry entry for NCT01911169 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT01911169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01911169 about?
NCT01911169 is a clinical study titled "Vitamin D to Improve Endothelial Function in SLE". Determine the effect of vitamin D repletion on flow mediated dilation (FMD, a measure of endothelial function) in vitamin D deficient systemic lupus erythematosus (SLE) patients. The investigators will enroll vitamin D deficient SLE patients and randomize them to receive either 400 IU or 5,000 IU of...
What is the current status of trial NCT01911169?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2011-06. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01911169?
The interventions under investigation include: Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT01911169?
This trial is sponsored by Medical University of South Carolina, which has 755 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.