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

University of Alexandria

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: vitamin D 25(OH)D; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01425775

alexmed116618166

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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248 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

Treatment:

Drug: vitamin D 25(OH)D

Placebo

Placebo Comparator group

Treatment:

Other: Placebo