A randomized clinical trial considering the effect of vitamin D supplementation on control of disease activity in rheumatoid arthritis patients patients

Objectives: The aim of this study is evaluation of the safety and efficacy of vitamin D in the management of rheumatoid arthritis patients. Design, setting and conduct: In a randomized single blind study in specialty clinics’ of Tabriz University of Medical Sciences, rheumatoid arthritis patients after explaining the study aim and obtaining written informed consent will recruit to the study. They will divide accidentally according to the two last number two groups. Disease activity of all patients will be measured by Disease activity score 28 (DAS28). Participants: Rheumatoid arthritis patients which their disease diagnosed according the American college of rheumatology 1987 criteria and have active disease (DAS28>2.6). Exclusion criteria: Use of vitamin D supplements in the past 6 months; pregnancy; liver and kidney disease; treatment with anticonvulsion drugs Intervention: A group of patients will receive 50,000 IU of vitamin D monthly for 6 months and control group nothing. All patients will be visited every 2 months and DAS 28 will be measured by a rheumatologist who doesn’t know the patients received vitamin D or no. Two groups will treat with a standard protocol with prednisolone 5-15 mg/d, escalating dose of methotrexate 7.5-25 mg/week and hydroxychloroquine 400 mg/d. In the treatment resistant patients we will add sulfasalazin 1500-2000 mg/d and then cyclosporine 3 mg/kg/d. Main outcome measures: Disease activity measured by DAS28. The clinical examination was done by a rheumatologist and DAS28 was calculated using the numbers of swollen and tender joints, C-reactive protein (CRP) and patient general health by the patient using visual analog scale (VAS) [online at www.das-score.nl]. Paired t test will be use for considering DAS28 in treatment and control group.

Vice chancellor for research, Tabriz university of medical sciences