CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Cholecalciferoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01911169
NCT01911169Phase 2Completed

Vitamin D Repletion to Improve Endothelial Function in Lupus Patients

Medical University of South Carolina·interventional·Posted Jul 30, 2013·Updated Oct 27, 2017

In Brief

A Phase 2 clinical trial evaluating Cholecalciferol for Atherosclerosis and Systemic Lupus Erythematosus. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2013
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.9 years ago

Interventions

Cholecalciferoldrug

5,000 International units versus 400 international units as an active comparator