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Effect of Folic Acid on Motor Aspects of Daily Living and Oxidative Stress in Levodopa Treated Parkinson's Disease Patients

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05959044
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Folic Acid Tablet
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 16, 2023
Anticipated Primary Completion Date :
Jul 16, 2024
Anticipated Study Completion Date :
Jul 16, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Effect of folic acid on motor aspects of daily living in levdopa treated of Parkinson's disease patients [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.

    Secondary Outcome Measures

    1. Serum homocysteine [8weeks]

      will be measured before and after intervention

    2. Serum malondialdehyde level [8weeks]

      will be measured before and after intervention

    3. Serum glutathion [8weeks]

      will be measured before and after intervention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BSMMU Dhaka Bangladesh 1000

    Sponsors and Collaborators

    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Shimu Akter Ayshi, MD Resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    ClinicalTrials.gov Identifier:
    NCT05959044
    Other Study ID Numbers:
    • BSMMU/2023/6247
    First Posted:
    Jul 25, 2023
    Last Update Posted:
    Jul 25, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Folic Acid

    Study Results

    No Results Posted as of Jul 25, 2023