Study on different doses of folic acid for supplementation with methotrexate in patients with rheumatoid arthritis

Randomized Trial of 10 mg versus 30 mg per week of Folic acid in combination with methotrexate in rheumatoid arthritis - FOLVARI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002510

Enrollment

140

Registered

2012-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: null- Rheumatoid Arthritis

Interventions

Intervention1: Folic acid: 10 mg per week (5mg x 2 days per week + placebo x 4 days a week, no tablet on day patient takes methotrexate) for 24 weeks Control Intervention1: Folic acid: 30 mg per week

Eligibility

Inclusion criteria

Inclusion criteria: i. Age 18-75 years ii. Patients fulfilling the 1987 American College of Rheumatology Rheumatoid arthritis criteria iii. On MTX over 15 mg per week iv. On folic acid 5 mg 6/7 days of week (30 mg per week)

Exclusion criteria

Exclusion criteria: i. Hb less than 8 g per dl or TLC less than 3500 or Platelet less than 1 lac or SGOT or SGPT more than 60 U/L ii. On irregular dose of folic acid.

Design outcomes

Primary

Measure	Time frame
1. Adverse effects due to methotrexate a. Minor adverse effects: By symptom chart a. Major adverse effects: Cytopenia (predefined) and transaminitis. 2. Disease activity using Disease activity score 28 joints (3 variables)Timepoint: 0,8,16,24 weeks	—

Secondary

Measure	Time frame
1. Serum and RBC folic acid 2. Functional status of patient by indian HAQTimepoint: 0 and 24 weeks	—

Countries

India

Contacts

Public ContactVarun Dhir

PGIMER, Chandigarh

varundhir@gmail.com91-8872229998

Outcome results

None listed

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