Effect of Folic Acid on Motor Aspects of Daily Living and Oxidative Stress in Levodopa Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo Controlled Trial

Trial ID: NCT05959044

Interventional - Phase 2 - Unknown status

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.

Conditions

• Parkinson Disease

Interventions

• Folic Acid Tablet
• Placebo

Eligibility

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

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Last updated: 2025-05-26 · Source: Clinicaltrials.gov

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