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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Abou-Raya, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier:
NCT01425775
First received: August 18, 2011
Last updated: August 27, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Systemic Lupus Erythematosus
Drug: vitamin D 25(OH)D
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • Decrease in SLE disease activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D Drug: vitamin D 25(OH)D
2000IU/day for 12 months
Placebo Comparator: Placebo Other: Placebo
2000IU/day of vitamin D will be compared to similar looking tablets of placebo for 12 months

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01425775

Locations
Egypt
Faculty of Medicine, University of Alexandria
Alexandria, Egypt, 00203
Sponsors and Collaborators
Faculty of Medicine, University of Alexandria
Investigators
Principal Investigator: Anna Abou-Raya, MD Faculty of Medicine, University of Alexandria
  More Information

No publications provided by Faculty of Medicine, University of Alexandria

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Abou-Raya, Professor of Rheumatology, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier: NCT01425775     History of Changes
Other Study ID Numbers: alexmed116618166
Study First Received: August 18, 2011
Last Updated: August 27, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Faculty of Medicine, University of Alexandria:
SLE
disease activity markers
vitamin D

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014