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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 parkinson-disease
Started Apr 2023
Shorter than P25 for phase_2 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2023
CompletedFirst Submitted
Initial submission to the registry
July 15, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2024
CompletedSeptember 26, 2023
September 1, 2023
1.3 years
July 15, 2023
September 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Serum homocysteine
8weeks
Serum malondialdehyde level
8weeks
Serum glutathion
8weeks
Study Arms (2)
Folic acid
ACTIVE COMPARATOR30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
Control
PLACEBO COMPARATOR30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
Interventions
oral 5mg tablet two times daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BSMMU
Dhaka, 1000, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Resident
Study Record Dates
First Submitted
July 15, 2023
First Posted
July 25, 2023
Study Start
April 16, 2023
Primary Completion
July 16, 2024
Study Completion
July 16, 2024
Last Updated
September 26, 2023
Record last verified: 2023-09