Does giving higher dose of folic acid improve intolerance associated with methotrexate in patients of Rheumatoid arthritis

ASSESSING THE EFFECT OF INCREASING THE DOSE OF FOLIC ACID SUPPLEMEMENTATION IN PATIENTS OF RHEUMATOID ARTHRITIS WITH METHOTREXATE INTOLERANCE – A RANDOMISED CONTROLLED TRIAL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051346

Enrollment

150

Registered

2023-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: Supplementation of higher dose folic acid in patients of RA on methotrexate with intolerance: Supplementation of two extra tablets of Folic acid 5mg per week (vs placebo) in addition to

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years 2. Diagnosis of RA made as per ACR EULAR 2010 criteria 3. Currently receiving methotrexate for more than 3 months 4. Methotrexate Intolerance Severity Assessment Score >4 qualifying as methotrexate intolerance

Exclusion criteria

Exclusion criteria: Unable to follow up at 16 weeks

Design outcomes

Primary

Measure	Time frame
Change in primary intolerances at 16 weeks by MISA scoreTimepoint: Change in primary intolerances at 16 weeks by MISA score	—

Secondary

Measure	Time frame
Change in DAS 28 3 variable score at 16 weeksTimepoint: 16 weeks;Change in RBC/Serum folate at the end of 16 weeksTimepoint: 16 weeks	—

Countries

India

Contacts

Public ContactHarshith Sai Koneti

PGIMER, Chandigarh

varundhir@gmail.com

Outcome results

None listed

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