The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease.
Vitamin D has potent immunomodulatory properties that have promoted its potential use in the
treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE
patients and determined alterations in inflammatory, hemostatic markers as well as disease
activity before and after vitamin D supplementation.
248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were
randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months.
Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18,
TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12
months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were
measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were
classified as vitamin D insufficiency, and levels < 10 ng/ml as vitamin D deficiency.The mean
25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.
Phase:
N/A
Details
Lead Sponsor:
Faculty of Medicine, University of Alexandria University of Alexandria