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

September 23, 2023 updated by: Dr. Shimu Akter Ayshi, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 8 weeks
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
Time Frame: 8weeks
will be measured before and after intervention
8weeks
Serum malondialdehyde level
Time Frame: 8weeks
will be measured before and after intervention
8weeks
Serum glutathion
Time Frame: 8weeks
will be measured before and after intervention
8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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