Phase 2 N=9 Randomized Quadruple-blind Prevention

Vitamin D to Improve Endothelial Function in SLE

Atherosclerosis · Systemic Lupus Erythematosus

Bottom Line

View on ClinicalTrials.gov: NCT01911169 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D — 1.4; -4.2 Absolute change in % FMD — p=> 0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cholecalciferol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D	1.4; -4.2	> 0.05
SECONDARY Change in Interferon Signature	—	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01911169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.