The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: vitamin D 25(OH)D; Other: Placebo

• Registration Number: NCT01425775
• Lead Sponsor: University of Alexandria

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-09
• Study Completion: 2011-05
• Status Verified: 2011-08
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-27
• Last Update Submitted: 2011-08-27
• Study First Posted: 2011-08-30
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• Premenopausal women and males of the same body mass index and ethnicity

Exclusion Criteria

Patients with:

• other inflammatory disorders,
• hepatic disease
• renal disease
• malignant disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	vitamin D 25(OH)D	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Decrease in SLE disease activity	12 months

Trial Locations

Locations (1)

Faculty of Medicine, University of Alexandria; 🇪🇬 Alexandria, Egypt