Folic Acid 1 MG for Parkinson's (NCT06772220)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 10 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.