Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06772220
Status
Recruiting
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Conditions

  • Parkinson&Amp;#39;s Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Folic Acid 1 MG — DIETARY_SUPPLEMENT
    Folic Acid 1mg per day
  • Vitamin B6 25 MG — DIETARY_SUPPLEMENT
    Vitamin B6, 25mg per day
  • Vitamin B12 — DIETARY_SUPPLEMENT
    Vitamin B12, 1,000 ug per day

Study Details

This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa. We are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function.

Key Dates

Start date
Mar 5, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B vitamin regimen
    Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.
  • No Intervention: No vitamins
    No vitamin intervention.

Primary Outcome Measure

Hyperhomocysteinemia and B vitamin deficiency [ Time Frame: baseline measurement ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science University (OHSU)PortlandOregon97239
Madeline Armendariz Sullivan
[email protected]
503-501-8478

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By research site
Oregon Health & Science University (OHSU)· Portland, OR

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