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 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.

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 it safe to use B vitamins for Parkinson's disease?

B vitamins, which help manage homocysteine levels, are generally considered safe, but elevated homocysteine is linked to risks like heart disease and stroke. While B vitamins might help reduce these risks, no controlled studies have confirmed their safety specifically for Parkinson's patients. ^{1 2 3 4 5}

How does the treatment for Parkinson's disease using B vitamins differ from other treatments?

This treatment is unique because it focuses on managing homocysteine levels, which are linked to neurodegeneration in Parkinson's disease, by using B vitamins like folate, B12, and B6. Unlike other treatments, it may provide benefits through antioxidant effects and dopamine synthesis, rather than just lowering homocysteine levels. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Homocysteine Management Therapy for Parkinson's Disease?

Research suggests that higher dietary intakes of folate, vitamin B12, and vitamin B6, which are involved in homocysteine metabolism, might decrease the risk of Parkinson's Disease by lowering plasma homocysteine levels. Additionally, vitamin B6 may have antioxidant effects and play a role in dopamine synthesis, potentially influencing Parkinson's Disease risk. ^{1 3 4 8 9}

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

I have been diagnosed with Parkinson's Disease.

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

Montreal Cognitive Assessment (MOCA) score ≥15

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

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 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]

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]

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]

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]

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]

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 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. United States pubmed.ncbi.nlm.nih.gov

Relationship of Cerebrospinal Fluid Vitamin B12 Status Markers With Parkinson's Disease Progression. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Clinical course in Parkinson's disease with elevated homocysteine. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dietary folate, vitamin B12, and vitamin B6 and the risk of Parkinson disease. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Plasma homocysteine levels and Parkinson disease: disease progression, carotid intima-media thickness and neuropsychiatric complications. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Plasma homocysteine levels in patients treated with levodopa: motor and cognitive associations. [2022]

6. Singapore pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Homocysteine and levodopa: should Parkinson disease patients receive preventative therapy? [2019]

8. Netherlands 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. [2013]

9. Austria pubmed.ncbi.nlm.nih.gov

Moderate hyperhomocysteinaemia and immune activation in Parkinson's disease. [2015]