Folic acid's effect on Parkinson's patients taking levodopa
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
This study is testing if taking folic acid can help people with Parkinson's who are on levodopa feel better and reduce side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT05959044 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of folic acid supplementation on patients with Parkinson's disease who are being treated with levodopa. It is a randomized, double-blind, placebo-controlled study conducted at Bangabandhu Sheikh Mujib Medical University, where 60 patients will be assigned to receive either folic acid or a placebo for 8 weeks. The study aims to assess the safety and efficacy of folic acid in reducing levodopa-induced side effects and improving overall symptoms of Parkinson's disease. Evaluations will be conducted using the MDS-Unified Parkinson's Disease Rating Scale at baseline and after the treatment period.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with mild to moderate Parkinson's disease who have been on levodopa for at least 6 months and have elevated homocysteine levels.
Not a fit: Patients with secondary parkinsonism, those who have undergone prior stereotactic surgery, or individuals with known hypersensitivity to folic acid may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of Parkinson's disease by reducing side effects associated with levodopa treatment.
How similar studies have performed: Previous studies have shown promising results in animal models regarding the benefits of folic acid in reducing levodopa-induced dyskinesia, but this specific approach in humans is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka
- Bsmmu — Dhaka, Bangladesh (Recruiting)
Study contacts
- Study coordinator: Shimu Akter Ayshi, MBBS
- Email: ayshi.somc@gmail.com
- Phone: +8801553719880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.