Efficacy of Vitamin D Supplementation among Newly Diagnosed Cases of Rheumatoid Arthritis Proposed to be Managed by Methotrexate Monotherapy: A Randomised Controlled Study

Abstract

Introduction: Methotrexate (MTX) has been the main drug that has been used worldwide for the treatment of Rheumatoid Arthritis (RA) either as a monotherapy or in combination with other Disease Modifying Antirheumatic Drugs (DMARD). Vitamin D deficiency has been shown to play an important role in the pathogenesis and progression of RA and its supplementation could have a promising role in management of RA. Aim: To evaluate the efficacy of vitamin D supplementation among newly diagnosed of RA cases scheduled for MTX monotherapy. Materials and Methods: This randomised controlled study was done at Era’s Lucknow Medical College and Hospital, Lucknow, India from January 2016 to December 2017. A total of 100 newly diagnosed patients of RA (p<0.001) were randomised to two groups: group A (n=50) received MTX monotherapy supplemented with 400 IU 25 Hydroxy [25(OH)] vitamin D twice a day (case group) whereas group B (n=50) received MTX monotherapy with placebo. Serum 25 Hydroxy vitamin D (S. 25 OH), American College of Rheumatology (ACR) score, Erythrocyte Sedimentation Rate (ESR) and Serum C-Reactive Protein (S. CRP) were assessed at enrolment, 3 months and 6 months. Data was analysed using Statistical Package for Social Sciences software (SPSS) version 21.0 software. Chi-square and Independent samples t test were used to compare the data. Results: Overall majority of patients were females 57% and 43% were males with mean age 40.98±8.83 years (range 26-60 years). At baseline, mean vitamin D levels were 22.94±12.41 and 25.54±12.79 ng/mL in groups A and B respectively (p-value>0.305). Mean ACR scores at baseline, 3 months and 6 months were 7.06±0.77, 5.16±1.11 and 4.42±0.93 respectively in group A and 7.02±0.74, 5.78±0.98 and 5.11±1.11 respectively in group B. At final follow-up, mean reduction in ACR scores and S. CRP levels was significantly higher in group A as compared to that in group B (p-value<0.001). Simultaneously, there was a significantly higher increase in vitamin D levels in group A as compared to that in group B (p-value<0.001). Conclusion: Vitamin D supplementation helped to potentiate the efficacy of MTX monotherapy in RA. Vitamin D deficiency causes diffuse musculoskeletal pain and its supplementation is needed for osteoporosis prevention.