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Vitamin D Supplementation in Rheumatoid Arthritis

A Prospective Randomized, single centre, two arm open label trial to evaluate the efficacy of daily and weekly high dose vitamin D (Cholecalciferol) in Rheumatoid Arthritis patients â?? A Pilot Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032530
Enrollment
50
Registered
2021-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Cholecalciferol: 60000 IU Weekly Once for 10 Weeks- Group A and 60000 IU daily Once for 10 days- Group B Intervention2: Cholecalciferol: 60000IU Daily once for 10 days Control Interven

Sponsors

Dr Arindam Nandy Roy
Lead Sponsor

Eligibility

Inclusion criteria

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 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

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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: At Day 0 i.e Baseline and At Day 90 i.e End of Study—

Secondary

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

Countries

India

Contacts

Public ContactDr Arindam Nandy Roy

Yashoda Hospitals

doctor.arindam@yahoo.com9849279830

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026