search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Folic Acid Tablet
Placebo
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BSMMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Folic acid

Control

Arm Description

30 patinets will receive Orally 5mg tablet two times daily for 8 weeks

30 patinets will receive Orally 5mg tablet two times daily for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum homocysteine
will be measured before and after intervention
Serum malondialdehyde level
will be measured before and after intervention
Serum glutathion
will be measured before and after intervention

Full Information

First Posted
July 15, 2023
Last Updated
September 23, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
search

1. Study Identification

Unique Protocol Identification Number
NCT05959044
Brief Title
Effect of Folic Acid in Levodopa Treated Parkinson's Disease Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2023 (Actual)
Primary Completion Date
July 16, 2024 (Anticipated)
Study Completion Date
July 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Folic acid
Arm Type
Active Comparator
Arm Description
30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Folic Acid Tablet
Other Intervention Name(s)
Vitamin B-9,Folison
Intervention Description
oral 5mg tablet two times daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
orally 5mg two times daily for 8weeks
Primary Outcome Measure Information:
Title
Effect of folic acid on motor aspects of daily living in levdopa treated of Parkinson's disease patients
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Serum homocysteine
Description
will be measured before and after intervention
Time Frame
8weeks
Title
Serum malondialdehyde level
Description
will be measured before and after intervention
Time Frame
8weeks
Title
Serum glutathion
Description
will be measured before and after intervention
Time Frame
8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimu Akter Ayshi, MBBS
Phone
+8801553719880
Email
ayshi.somc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Md.Sayedur Rahman, FCPS, Mphil
Phone
+8801712205305
Email
srkhasru@bsmmu.edu.bd
Facility Information:
Facility Name
BSMMU
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shimu Akter Ayshi, MBBS
Phone
+8801553719880
Email
ayshi.somc@gmail.com
First Name & Middle Initial & Last Name & Degree
Md. Sayedur Rahman, FCPS,Mphil
Phone
+8801712205305
Email
srkhasru@bsmmu.edu.bd

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs