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

NCT01425775 | Completed DMC

• 1 other identifier: alexmed116618166
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; disease activity markers; vitamin D

Outcome Measures

Primary Outcomes (1)

• Decrease in SLE disease activity

  12 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Drug: vitamin D 25(OH)D

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

vitamin D 25(OH)D DRUG

2000IU/day for 12 months

Vitamin D

Placebo OTHER

2000IU/day of vitamin D will be compared to similar looking tablets of placebo for 12 months

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with:
• other inflammatory disorders,
• hepatic disease
• renal disease
• malignant disease.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine, University of Alexandria

Alexandria, 00203, Egypt

Location

Related Publications (1)

• Abou-Raya A, Abou-Raya S, Helmii M. The effect of vitamin D supplementation on inflammatory and hemostatic markers and disease activity in patients with systemic lupus erythematosus: a randomized placebo-controlled trial. J Rheumatol. 2013 Mar;40(3):265-72. doi: 10.3899/jrheum.111594. Epub 2012 Dec 1.

  PMID: 23204220 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anna Abou-Raya, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 30, 2011
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: May 1, 2011
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

EG (1)