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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425775
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):
Anna Abou-Raya, 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: vitamin D 25(OH)D Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Decrease in SLE disease activity [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01425775

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anna Abou-Raya, Professor of Rheumatology, University of Alexandria Identifier: NCT01425775    
Other Study ID Numbers: alexmed116618166
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011
Keywords provided by Anna Abou-Raya, University of Alexandria:
disease activity markers
vitamin D
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents