Health Condition 1: M080- Unspecified juvenile rheumatoid arthritis
Conditions
Interventions
Intervention1: 10mg Folic Acid Supplementation: Folic Acid Tablet 10mg Per Oral once Weekly for 2 months
Control Intervention1: 5mg Folic Acid Supplementation: Folic Acid Tablet 5mg Per Oral once Week
Sponsors
AIIMS PATNA
Eligibility
Inclusion criteria
Inclusion criteria: Yes
Exclusion criteria
Exclusion criteria: Participants were excluded if they had a change in dose or introduction of another DMARD, nonsteroidal anti-inflammatory agent or oral steroid within the preceding month, or intra-articular steroid injection within 1 month before enrolment. 1. Children with a history of hypersensitivity or allergic reactions to folic acid, methotrexate, or other disease-modifying anti-rheumatic drugs (DMARDs). 2. Treatment with higher doses of MTX ( > 20 mg/m2/week). 3. Children with any other autoimmune or rheumatic diseases other than JIA. 4. Children who are already taking a folic acid supplement in a dose of more than 400 mcg per day. 5. Children who have participated in any other clinical trial within the past 3 months. 6. Patients with chronic liver disease or other conditions that could increase the risk of hepatotoxicity. 7. Patients on other DMARDs or Biologicals 8. Preexisting contraindication to MTX (Patients having anemia, severe transaminitis) 9. Those having good disease control on NSAIDs 10. Patients having MAS ( Macrophage Activation Syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study was to determine the optimal dose of folic acid for reducing the side effects of methotrexate in children with JIA. The study aims to compare the effectiveness of two different doses of folic acid (5mg/week & 10mg/week) in reducing methotrexate toxicity. Timepoint: At Baseline and at 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of two different doses of folic acid (5 mg/week folic acid versus 10 mg/week ) on the efficacy of MTX therapyTimepoint: • Baseline assessment: The baseline assessment will be performed before starting the study medication. (Visit 1) • Follow-up visits: The patients will be followed up at 8 weeks after starting the study medication. (Visit 2) | — |
Countries
India
Contacts
Public ContactMrinmoy Das
AIIMS PATNA
Outcome results
None listed