Role of Vitamin D3 Supplementation With Conventional Synthetic Disease Modifying Antirheumatic Drugs(csDMARD) in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Several studies suggested low serum level of vitamin D have been associated with rheumatoid
      arthritis. So, the present study was designed to investigate the effect of vitamin D
      supplementation along with CsDMARD in patients with rheumatoid arthritis.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that causes synovitis
      in the peripheral joints as well as extra-articular symptoms. With a good response to
      conventional drugs, treatment for this disease remains unsatisfactory. Vitamin D deficiency
      is now widely recognized as a problem in RA patients. Some recent trials have attempted to
      analyze the effect of vitamin D3 supplementation on pain intensity and disease activity in
      patients, and the majority of them have found significant improvement. The goal of this trial
      was to see if supplementing vitamin D3 with conventional synthetic DMARDs improved the
      intensity of pain and disease activity in RA patients. This study was a randomized,
      double-blind, placebo-controlled trial and was conducted in the Department of Pharmacology,
      BSMMU in collaboration with the Rheumatology Rehabilitation Clinic of the Department of
      Physical Medicine and Rehabilitation, BSMMU. Patients were assessed using a validated version
      of the visual analog scale (VAS) and the DAS-28 CRP scale. A total of 58 RA patients were
      selected based on inclusion and exclusion criteria, and baseline CRP levels were measured
      serum preserved for vitamin D3 estimation. A physiatrist at the Physical Medicine and
      Rehabilitation department's Rheumatology Rehabilitation Clinic performed the clinical
      diagnosis of RA patients. Following the completion of the necessary formalities, including
      the patients' informed consent, the patient has given a Visual Analog Scale (VAS)
      questionnaire to assess pain improvement and a disease activity score -28 C-Reactive Protein
      (DAS-28 CRP) scale to assess disease activity. The patients were split into two arms at
      random: intervention and control. Patients in the intervention arm received csDMARDs plus
      vitamin D3 (40,000IU) for 8 weeks. Weekly oral vitamin D3 (40,000IU) was given to the
      intervention arm. On the other hand, The placebo arm got csDMARD in the form of one oral
      placebo capsule once a week for the same duration of time. After 8 weeks of therapeutic
      intervention, blood samples were taken to determine serum 25 hydroxyvitamin D and CRP levels.
      The baseline and after 8 weeks serum 25 hydroxyvitamin D levels were estimated at the same
      time. The patient's compliance sheet, as well as the phone and pill count, were used to
      verify that medicine intake was regular. Microsoft Office Excel 2007 was used to perform the
      statistical analysis. A chi-squared test was used to analyze the relationship between the
      intervention and placebo arms. An unpaired t-test was used to compare the scores of the two
      arms. A paired t-test was employed to compare the score before and after the intervention. A
      total of 58 people were enrolled in this study over six months. Following decoding, it was
      established that twenty-nine (30) patients would receive vitamin D3 and twenty-three (28)
      would receive a placebo. Among them, fifty-two (52) patients met all criteria to be eligible
      for analysis. There was a substantial difference in improving disease activity and pain
      severity between the two arms (p-value- 0.00). All of the RA patients were vitamin D
      deficient. Vitamin D3 supplementation for 8 weeks resulted in a significantly higher level
      than the placebo arm (p- 0.01), as well as a significant increase from the baseline level (p-
      0.04). After 8 weeks of vitamin D3 administration, CRP levels were significantly reduced
      (p-0.00). There was no correlation between serum 25-hydroxyvitamin D levels and disease
      activity. Vitamin D3 significantly reduced the intensity of pain and disease activity in
      conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARD) treated Rheumatoid
      Arthritis patients.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): One capsule of vitamin D3(40000IU) weekly for 8 weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment