B Vitamins for Parkinson's Disease

Overseen By Madeline Armendariz Sullivan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must be taking: Levodopa

Disqualifiers: Uncontrolled hypertension, Insulin use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether B vitamins can lower homocysteine levels in people with Parkinson's disease who take levodopa, a common medication. High homocysteine might affect thinking skills, so the study examines how B vitamins could help. Participants will either take a daily dose of B vitamins (called Homocysteine Management Therapy) or no vitamins. This trial may suit those diagnosed with Parkinson's, taking at least 300 mg of levodopa daily, and experiencing memory or thinking issues. As an unphased trial, it offers a unique opportunity to contribute to understanding potential new benefits of B vitamins for Parkinson's patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you continue taking levodopa at a minimum dose of 300 mg per day.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that B vitamins, such as B12, B6, and folic acid, can help manage high homocysteine levels in people with Parkinson's disease. Some studies found that these vitamins can lower homocysteine levels, which medications like levodopa can increase. High homocysteine levels can be harmful, so reducing them is beneficial.

Regarding safety, B vitamins are generally well-tolerated. Research indicates they are safe for most people when taken in recommended amounts. Studies involving these vitamins have not reported major serious side effects. Therefore, taking a combination of B12, B6, and folic acid in this context appears safe based on available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Parkinson's disease, which often focus on managing symptoms with medications like levodopa, this approach uses a specific B vitamin regimen to target elevated homocysteine levels. Homocysteine is a compound in the blood that, when elevated, is thought to be linked to worse outcomes in Parkinson's disease. Researchers are excited because this treatment could potentially slow disease progression rather than just address symptoms. By using daily doses of folic acid, vitamin B6, and vitamin B12, this regimen aims to manage homocysteine levels, offering a novel mechanism beyond the traditional dopamine-centric therapies.

What evidence suggests that this trial's B vitamin regimen could be effective for managing elevated homocysteine in Parkinson's disease?

Research has shown that vitamins B12, B6, and folic acid can help lower high homocysteine levels, which levodopa, a common treatment for Parkinson’s disease, can cause. Lowering homocysteine is important because high levels link to memory and thinking problems. In this trial, participants in the B vitamin regimen arm will receive daily doses of these vitamins. Some studies suggest that vitamin B6 might also lower the risk of developing Parkinson's disease, although this might not relate to homocysteine levels. It's important to understand that while these vitamins may help with homocysteine, they do not necessarily lower the risk of Parkinson's itself. However, maintaining healthy vitamin B12 levels might support nerve function, which could benefit people with Parkinson's. ^{1 2 4 6 7}

Who Is on the Research Team?

Joseph Quinn, MD

Principal Investigator

Oregon Health & Science University (OHSU)

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who are currently being treated with levodopa and have high homocysteine levels in their blood. The study aims to see if B vitamins can lower these levels and help with cognitive function.

Inclusion Criteria

Montreal Cognitive Assessment (MOCA) score ≥15

I have been diagnosed with Parkinson's Disease.

I am currently taking at least 300 mg of levodopa daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open label B vitamin therapy to manage homocysteine levels

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Homocysteine Management Therapy

Trial Overview The study tests whether a combination of B vitamins (Folic Acid, Vitamin B6, and Vitamin B12) can reduce elevated homocysteine levels in the blood of Parkinson's patients on levodopa therapy.

How Is the Trial Designed?

Group I: B vitamin regimen Experimental Treatment 3 Interventions

Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.

Group II: No vitamins Active Control 1 Intervention

No vitamin intervention.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

B vitamin supplementation, particularly folic acid, can reduce the severity of Parkinsonism in rats, as shown by improved performance in motor tests, indicating a potential therapeutic effect.

Interestingly, the anti-Parkinsonism benefits of B vitamins do not appear to be linked to lowering homocysteine levels, as some groups showed increased Hcy despite treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intake of folic acid or complex of B vitamins provides anti-Parkinsonism effect: no role for serum level of homocysteine. Haghdoost-Yazdi, H., Fraidouni, N., Faraji, A., et al.[2013]

In untreated early Parkinson's disease patients, low levels of cerebrospinal fluid (CSF) vitamin B12 were linked to a greater decline in walking ability, as measured by the UPDRS 'walking' item.

Unlike vitamin B12, high levels of total homocysteine in CSF did not show a connection to cognitive decline, suggesting that B12 may play a more critical role in physical progression of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of Cerebrospinal Fluid Vitamin B12 Status Markers With Parkinson's Disease Progression. Christine, CW., Auinger, P., Saleh, N., et al.[2021]

In a study of 5,289 older adults over a mean follow-up of 9.7 years, higher dietary intake of vitamin B6 was linked to a significantly lower risk of developing Parkinson's disease, particularly among smokers.

No significant associations were found between dietary intake of folate or vitamin B12 and the risk of Parkinson's disease, suggesting that vitamin B6 may have protective effects through mechanisms beyond its role in homocysteine metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary folate, vitamin B12, and vitamin B6 and the risk of Parkinson disease. de Lau, LM., Koudstaal, PJ., Witteman, JC., et al.[2022]

Parkinson's disease (PD) patients exhibit significantly higher levels of homocysteine (Hcy) and lower levels of vitamin B12 and folate compared to healthy individuals, suggesting a potential link between these biomarkers and the disease.

Patients with PD who have cognitive impairment or neuropathy show even greater increases in Hcy and further decreases in vitamin B12 and folate, indicating that these nutrients may play a role in the cognitive and neurological complications associated with PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features of Plasma Homocysteine, Vitamin B12, and Folate in Parkinson's Disease: An Updated Meta-Analysis. Liu, Y., Gou, M., Guo, X.[2023]

In a study of 97 individuals with early Parkinson's disease over 2 years, elevated homocysteine levels did not significantly predict worse cognitive, affective, or motor progression (p = 0.20).

While there was a noted trend towards higher mortality in those with elevated homocysteine (4 deaths in the elevated group vs. 1 in the normal group, p = 0.03), the small number of deaths limits the conclusions that can be drawn.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical course in Parkinson's disease with elevated homocysteine. O'Suilleabhain, PE., Oberle, R., Bartis, C., et al.[2022]

Elevated serum homocysteine levels have been linked to an increased risk of coronary artery disease, stroke, and dementia, and this elevation has also been observed in patients with Parkinson's disease (PD).

The primary cause of increased homocysteine in PD patients appears to be the use of L-dopa therapy, which may raise concerns about the potential risks of stroke, heart disease, and cognitive decline in these patients, although controlled studies are still ongoing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Homocysteine and levodopa: should Parkinson disease patients receive preventative therapy? Postuma, RB., Lang, AE.[2019]

In a study of 72 Parkinson's disease patients, nearly 39% had elevated plasma homocysteine (Hcy) levels, which were linked to the duration of Parkinson's disease and L-dopa treatment, but not to disease severity or L-dopa dosage.

Despite the high prevalence of hyperhomocystinemia in these patients, there was no significant association found between Hcy levels and neuropsychological issues like depression, cognitive decline, or cardiovascular problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma homocysteine levels and Parkinson disease: disease progression, carotid intima-media thickness and neuropsychiatric complications. Hassin-Baer, S., Cohen, O., Vakil, E., et al.[2013]

Patients with idiopathic Parkinson's disease (IPD) had significantly higher homocysteine levels compared to healthy controls, which correlated positively with higher doses of levodopa and worse motor function as measured by the UPDRS.

While cognitive impairments were not observed in the overall patient group, those with hyperhomocysteinemia (homocysteine levels >14 micromol/l) performed significantly worse on frontal and memory tests, suggesting that monitoring and potentially supplementing folic acid and vitamin B12 could be beneficial for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma homocysteine levels in patients treated with levodopa: motor and cognitive associations. Ozer, F., Meral, H., Hanoglu, L., et al.[2022]

In a study of 19 Parkinson's disease patients aged 61-90, increased homocysteine levels were found to correlate with low folate and vitamin B12 concentrations, suggesting a link between vitamin deficiency and disturbed homocysteine metabolism.

The study also indicated that immune activation, as measured by neopterin levels, may contribute to folate depletion, highlighting a potential mechanism by which homocysteine levels are affected in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate hyperhomocysteinaemia and immune activation in Parkinson's disease. Widner, B., Leblhuber, F., Frick, B., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11311973/

The Impact of the Dietary Intake of Vitamin B12, Folic Acid ... The present trial aimed to examine whether the intake of vitamin B12, folic acid, and vitamin D3 supplements improved homocysteine level and quality of life ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322005051

Dietary Approaches to Improve Efficacy and Control Side ... Furthermore, supplementation of vitamin B-12, vitamin B-6, and folic acid successfully reduced high homocysteine concentrations that emerged from levodopa ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36938854/

Long-Term Intake of Folate, Vitamin B6, and Vitamin B12 and ... Our results do not support the hypothesis that a higher intake of folate or vitamin B6 would reduce PD risk in this population.

4. neurology.org neurology.org/doi/10.1212/01.wnl.0000225050.57553.6d

Dietary folate, vitamin B12, and vitamin B6 and the risk of ... Conclusions: Dietary vitamin B6 may decrease the risk of Parkinson disease, probably through mechanisms unrelated to homocysteine metabolism.

5. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(19)30177-6/fulltext

Low Vitamin B12 and Parkinson Disease Low vitamin B12 and Parkinson disease potential link to reduced cholinergic transmission and severity of disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4586528/

Associations between B Vitamins and Parkinson's Disease Available data suggested that higher dietary intake of vitamin B6 was associated with a decreased risk of PD (odds ratio (OR) = 0.65, 95% ...

7. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2023.1254824/full

Association between the risk and severity of Parkinson's ... Our results confirmed that PD patients had significantly higher Hcy levels compared to the controls, as well as lower folic acid and vitamin B12 levels. These ...