The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)
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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 |
- 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 |
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| Egypt | |
| Faculty of Medicine, University of Alexandria | |
| Alexandria, Egypt, 00203 | |
| Principal Investigator: | Anna Abou-Raya, MD | Faculty of Medicine, University of Alexandria |
More Information
No publications provided
| 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 Vitamin D Ergocalciferols |
Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 21, 2013