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Lupus flareups cut in half by just 2,000 IU of vitamin D – RCT Dec 2012

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

The Journal of Rheumatology jrheum.111594 Published online before print December 1, 2012,
Anna Abou-Raya, Suzan Abou-Raya and Madihah Helmii
From the Internal Medicine Department, Faculty of Medicine, University of Alexandria; the Biochemistry Department, Medical Research Institute; and the Alexandria Centre for Women’s Health, Alexandria, Egypt.
A. Abou-Raya, MD, Rheumatology and Immunology Department, Faculty of Medicine, University of Alexandria, and Alexandria Centre for Women’s Health; S. Abou-Raya, MD, Internal Medicine Department, Faculty of Medicine, University of Alexandria, and Alexandria Centre for Women’s Health; M. Helmii, MD, Biochemistry Department, Medical Research Institute.
Address correspondence to Dr. A. Abou-Raya, Faculty of Medicine, University of Alexandria, Rheumatology Division, Internal Medicine Department, 12 Heliopolis Street, Camp Cesar Alexandria, Alexandria 00203, Egypt. E-mail: annaaraya at yahoo.com.
Accepted for publication October 3, 2012.


Objective Systemic lupus erythematosus (SLE) is a chronic multisystem inflammatory autoimmune disease. Vitamin D has potent immunomodulatory properties that support its use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status in patients with SLE and determined alterations in inflammatory and hemostatic markers and disease activity before and after vitamin D supplementation.

Methods Patients with SLE (n = 267) 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 proinflammatory cytokines and hemostatic markers, and improvement in disease activity before and after 12 months of supplementation. Disease activity was measured by the SLE Disease Activity Index. Vitamin D levels were measured by Liaison immunoassay (normal 30–100 ng/ml). Serum levels between 10 and 30 ng/ml were classified as vitamin D insufficiency and levels < 10 ng/ml as vitamin D deficiency.

Results The mean 25(OH)D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls. The overall prevalence of suboptimal and deficient 25(OH)D serum levels among patients with SLE at baseline was 69% and 39%, respectively. Lower 25(OH)D levels correlated significantly with higher SLE disease activity. At 12 months of therapy, there was a significant improvement in levels of inflammatory and hemostatic markers as well as disease activity in the treatment group compared to the placebo group.

Conclusion Vitamin D supplementation in patients with SLE is recommended because increased vitamin D levels seem to ameliorate inflammatory and hemostatic markers and show a tendency toward subsequent clinical improvement. Clinical Trial Registry NCT01425775.

Vitamin D Council comment on the study Jan 2013

10% of patients in the vitamin D group experienced a flare-up, compared to 24% experiencing flare-ups in the placebo group over the course of the year (p<0.05).

The study concluded that:

  • “Vitamin D, a safe, inexpensive, and widely available agent, may be as effective as a disease-suppressing intervention for patients with SLE.”

See also VitaminDWiki

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