Vitamin D to Improve Endothelial Function in SLE

Completed · Phase 2

Conditions studied: Atherosclerosis, Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT01911169

Run by

Medical University of South Carolina

People needed

9

Starts

2011-06-01

Expected to finish

2014-01-01

Last updated by the study team

2017-10-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SLE per 1997 American College of Rheumatology Criteria(at least 4 criteria present)
• Documented Vitamin D deficiency
• Able to give informed consent

You may not qualify if…

• Using tobacco products
• Pregnant/Planning pregnancy
• Known Hypercalcemia (Serum Ca >10.4)
• Known Hypercalcuria (Calcium/Creatinine >0.8)
• Chronic active lupus nephritis or end stage renal disease or kidney stones
• Known Hyperparathyroidism
• Known chronic viral/mycobacterial infections
• Uncontrolled medical disease - Pl judgment
• Current drug or alcohol abuse
• Anticipated poor compliance/known neuropsychiatric disorders
• Hx of cardiovascular events (i.e. Ml, PVD, CVE)
• Subjects taking medications known to affect FMD in lupus subjects such as but not limited to fish oil, statins, will remain on stable doses throughout the study.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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