Effect of Folic Acid in Levodopa Treated Parkinson's Disease Patients

• Status: Recruiting
• Trial end date: 2024-07-16
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective single center, randomized, double-blind, 2 arm placebo-controlled study in subjects with Parkinson's disease receiving levodopa .The patients will be randomized to receive tablet Folic Acid 10 mg per day or placebo for 8 weeks. The safety and efficacy outcome measures will be assessed at baseline and 8 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Folic Acid

Criteria

Inclusion Criteria:

• Diagnosed PD patients taking levodopa for at least 6months.

• Mild to moderate Parkinson's disease patient according to Hoehn and Yahr staging, stage -I, II, III

• Homocysteine level ≥ 13 µmol/L

Exclusion Criteria:

• Secondary causes of parkinsonism

• Prior stereotactic surgery for PD

• Suffering from active malignancy

• Known hypersensitivity to folic acid

• Multivitamin supplementation within 30 days of enrollment

• Patients taking anticonvulsant, oral contraceptive pill, disease modifying anti-rheumatic drugs

• Pregnancy or lactating mother

• Has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed