Vitamin D Supplementation in Rheumatoid Arthritis

Not Applicable

• Conditions: Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

• Registration Number: CTRI/2021/04/032530
• Lead Sponsor: Dr Arindam Nandy Roy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Are between the age of 18 to 60.

2. Subjects of either gender with documented Vitamin D deficiency (Serum 25(OH) D level of <20 ng/ml ( <50 nmol/L).

3. Are clinically diagnosed with RA (according to ACR 2010 criteria) (7).

4. Have active disease defined by Simplified Disease Activity Index (SDAI) >3.3(8).

Exclusion Criteria

1. Hypersensitivity to cholecalciferol (Vitamin D).

2. Pregnant and lactating women.

3. History of renal or any metabolic disease.

4. Subjects having arthritis other than Rheumatoid.

5. Any illness that could impair their ability to comply with the study, or are enrolled in another study.

6. Subjects willing to stop calcium/Multivitamin supplements at the time of consent.

7. Plan to start with biological agents.

8. Mental illness impairing ability to comply with study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of the study is to compare the effect of oral high dose vitamin D 60000 IU taken daily for 10 days to weekly 60000 IU dose for 10 weeks in attaining optimal level at 3 months in Vitamin D deficient (Serum 25(OH) D level of 20 ng/ml (50 nmol/L) patients of Rheumatoid Arthritis. <br/ ><br> <br/ ><br>Timepoint: At Day 0 i.e Baseline and <br/ ><br>At Day 90 i.e End of Study

Secondary Outcome Measures

Name	Time	Method
To see effect of vitamin D supplementation on disease severity as assessed by Simplified Disease Activity Index (SDAI).Timepoint: 90 days