Vitamins lower blood homocysteine levels
- Trial ID
- NCT06772220
- Official Title
- Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
- Goal
- Vitamins lower blood homocysteine levels
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Oregon Health and Science University
- Study Type
- INTERVENTIONAL
- Enrollment
- 150 participants
- Conditions
- Parkinson&Amp;#39;s Disease
- Interventions
- Folic Acid 1 MG, Vitamin B6 25 MG, Vitamin B12
Summary For Families
The goal is to lower high homocysteine that can rise with levodopa use and may contribute to vascular problems and cognitive decline in people with Parkinson's. The approach gives daily folic acid 1 mg, vitamin B6 25 mg, and vitamin B12 to help the body convert homocysteine into methionine or cysteine, thereby lowering blood homocysteine levels; these supplements are intended to be added to existing levodopa treatment and generally do not reduce levodopa's benefit when used with standard decarboxylase inhibitors like carbidopa. The study is enrolling people ages 40 to 90 with probable Parkinson's who are taking at least 300 mg of levodopa per day, have a MOCA of 15 or higher, adequate kidney function, no uncontrolled high blood pressure, are not using insulin, and can give informed consent.
Locations
- Oregon Health & Science University (OHSU), Portland, Oregon, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Folic Acid 1 MG. The goal is to lower high homocysteine that can rise with levodopa use and may contribute to vascular problems and cognitive decline in people with Parkinson's. The approach gives daily folic acid 1 mg, vitamin B6 25 mg, and vitamin B12 to help the body convert homocysteine into methionine or cysteine, thereby lowering blood homocysteine levels; these supplements are intended to be added to existing levodopa treatment and generally do not reduce levodopa's benefit when used with standard decarboxylase inhibitors like carbidopa. The study is enrolling people ages 40 to 90 with probable Parkinson's who are taking at least 300 mg of levodopa per day, have a MOCA of 15 or higher, adequate kidney function, no uncontrolled high blood pressure, are not using insulin, and can give informed consent.
- Who can participate?
- Participants must be between 40 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 10 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.