Finding the Right Folic Acid Dose to Protect Kids with Arthritis from Medicine Side Effects
- Conditions
- Health Condition 1: M080- Unspecified juvenile rheumatoid arthritis
- Registration Number
- CTRI/2024/02/063239
- Lead Sponsor
- AIIMS PATNA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Yes
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method