Efficacy of Vitamin D Supplementation among Newly Diagnosed Cases of Rheumatoid Arthritis Proposed to be Managed by Methotrexate Monotherapy: A Randomised Controlled Study
Published: September 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/58232.16837
Yashasvi Bansal, Pulkesh Singh, Prateek Agrawal, Hemraj Saini
1. Research Fellow, Department of Orthopaedics, Sant Parmanand Hospital, New Delhi, New Delhi, India.
2. Associate Professor, Department of Orthopaedics, AIIMS, Raebareli, Raebareli, Uttar Pradesh, India.
3. Assistant Professor, Department of Orthopaedics, K.D Medical College, Hospital and Research Center, Mathura, Uttar Pradesh, India.
4. Assistant Professor, Department of Orthopaedics, K.D Medical College, Hospital and Research Center, Mathura, Uttar Pradesh, India.
Correspondence
Prateek Agrawal,
Prayag Hospital, Bhuteshwar Road, Mathura, Uttar Pradesh, India.
E-mail: prtk1986@gmail.com
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.
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