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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: Completed Phase 2 study, sponsored by Medical University of South Carolina.
NCT01911169 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measures were be performed with a Phillips iU22 Ultrasound system and a L9-3 9 mHz probe in 2D mode by a single operator using EKG gating. Baseline measures of brachial artery diameter will be made after the 10 minutes of rest. The blood pressure cuff, placed on the ipsilateral forearm, was inflated to 50 mmHg above the patient's systolic blood pressure for five minutes and then released. Endothelium-dependent FMD was measured continuously during and for three minutes after cuff release. Subject
Interventions
- DRUG Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT01911169 record still lists
NCT01911169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT01911169 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01911169's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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