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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Folic Acid Tablet; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shimu Akter Ayshi, MBBS; Phone Number: +8801553719880; Email: ayshi.somc@gmail.com
• Study Contact Backup: Name: Md.Sayedur Rahman, FCPS, Mphil; Phone Number: +8801712205305; Email: srkhasru@bsmmu.edu.bd

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Recruiting
    • BSMMU
    • Contact: Shimu Akter Ayshi, MBBS; Phone Number: +8801553719880; Email: ayshi.somc@gmail.com
    • Contact: Md. Sayedur Rahman, FCPS,Mphil; Phone Number: +8801712205305; Email: srkhasru@bsmmu.edu.bd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2023
• Primary Completion (Estimated): July 16, 2024
• Study Completion (Estimated): July 16, 2024

Study Registration Dates

• First Submitted: July 15, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: BSMMU/2023/6247

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No