Effect of Vitamin D supplementation in Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Health Condition 1: M069- Rheumatoid arthritis, unspecified

• Registration Number: CTRI/2021/04/033032
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-28
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Consenting adult patients with active rheumatoid arthritis (2010 ACR/EULAR criteria) on stable treatment for last 3 months

Exclusion Criteria

1. Overlap of rheumatoid arthritis and other autoimmune diseases,

2. Abnormal serum calcium, phosphorus, alkaline phosphatase ( > 2x ULN)

3. Vitamin D toxicity ( > 150 ng/ml) [28]

4. Refusal of consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the absolute change in CDAI values in participants receiving <br/ ><br>standard treatment along with vitamin D (60,000 IU/week x 6 weeks)Timepoint: Day 1 and day 90

Secondary Outcome Measures

Name	Time	Method
To assess change in quality of life using Indian HAQ, WHO-QOL BREF <br/ ><br>questionnairesTimepoint: Day 1 and Day 90;To assess effect of vitamin D supplementation on disease severity of <br/ ><br>fibromyalgiaTimepoint: Day 1 and Day 90;To assess pain relief using change in visual analog scoresTimepoint: Day 1 and Day 90;To assess proportion of participants achieving remission according to <br/ ><br>EULAR remission criteria (CDAI 2.8)Timepoint: Day 1 and Day 90