Recruiting

Homocysteine Management

Sponsor:

Oregon Health and Science University

Code:

NCT06772220

Conditions

Parkinson&Amp;#39;s Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Folic Acid 1 MG

Vitamin B6 25 MG

Vitamin B12

Study Details

Brief summary:

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.

Conditions

Parkinson&Amp;#39;s Disease

Study ID

NCT06772220

Start date

Mar 5, 2024

Status verified date

Jan, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria.
2. Currently treated with levodopa at a minimum dose of 300 mg/day
3. Montreal Cognitive Assessment (MOCA) ≥15
4. Demonstrated capacity to provide informed consent.
5. 40-90 years of age
6. Estimated glomerular filtration rate ≥60
7. Absence of uncontrolled hypertension in medical history
8. Absence of insulin use

Exclusion Criteria:

-

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Folic Acid 1 MG

Folic Acid 1mg per day

Vitamin B6 25 MG

Vitamin B6, 25mg per day

Vitamin B12

Vitamin B12, 1,000 ug per day

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Madeline Armendariz Sullivan

503-501-8478PDResearch@ohsu.edu

Locations

Oregon Health & Science University (OHSU)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Madeline Armendariz Sullivan

503-501-8478PDResearch@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jan 13, 2025

Last verified

Jan, 2025

Keywords

  • Parkinson's disease
  • Parkinson disease
  • homocysteine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-01-13.