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

Study Overview
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Brief Summary
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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.

Detailed Description
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Parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. Most commonly used drug, levodopa can improve the dopamine level in brain but levodapa causes hyperhomocysteinmia as a result increse neurotoxicity,oxidative stress and motor fluctuations and dyskinesia in many patients. Folic acid has been reduced homocystein level in levodopa treated Parkinson's disease on animal model and also reduced Levodopa induced dyskinesia without compromising the motor benefits of Levodopa. Therefore, the present study is to attempt to improve the sign symptoms of Parkinson's disease by giving folic acid along with Levodopa. This study is a Randomized, Double-Blind, Placebo-Controlled Trial and conducting at Department of Pharmacology, BSMMU in collaboration with Department of Neurology, BSMMU. A total of 60 patients suffering from Parkinson's disease is selected according to inclusion and exclusion criteria. The diagnosis of the patients suffering from Parkinson's disease will be performed by a neurologist at movement disorder clinic of department of Neurology, BSMMU. Patients will undergo MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to assess the severity of the disease. The patients will be randomly allocated into two arms: control and intervention. Patients in intervention arm consisted of 30 patients who will receive levodopa plus folic acid orally for 8 weeks. On the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. The severity of Parkinson's disease will be assessed 8 weeks follow up.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Folic Acid Tablet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Folic acid<br>30 patinets will receive Orally 5mg tablet two times daily for 8 weeks | Drug: Folic Acid Tablet<br>* oral 5mg tablet two times daily for 8 weeks<br>* Other names: Vitamin B-9,Folison;|
| Placebo Comparator: Control<br>30 patinets will receive Orally 5mg tablet two times daily for 8 weeks | Other: Placebo<br>* orally 5mg two times daily for 8weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of folic acid on motor aspects of daily living in levdopa treated of Parkinson's disease patients | Assessing and comparing the severity of symptoms of Parkinson's disease of two groups by using MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at baseline and 8 weeks following folic acid and placebo supplementation. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum homocysteine | will be measured before and after intervention | 8weeks | 
| Serum malondialdehyde level | will be measured before and after intervention | 8weeks | 
| Serum glutathion | will be measured before and after intervention | 8weeks |