Parkinson's Disease (PD)NCT07430722
Cross-sectional Study of Vitamin B6 in Parkinson's Disease
An observational study of Parkinson's Disease (PD), run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to estimate the prevalence of abnormal serum levels of vitamin B6, and the associations of those levels with demographic and clinical variables in a randomly selected sample of people living with Parkinson's disease, compared to historical controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease (PD)
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Participants will be randomly selected from the people living with Parkinson's disease who are followed at the Movement Disorders Clinic at the University of Rochester in Rochester, NY, USA. * Matched historical controls will be randomly selected from the publicly available National Health and Nutrition Examination Survey.
Who may be able to join
- People with a clinical diagnosis of Parkinson's disease according to the diagnostic criteria of the Movement Disorders Society [Postuma 2015].
- Participants are ≥ 18 years old.
- As determined by the study investigators, participants are able to communicate at a level sufficient to undergo study interviews.
- As determined by the study investigators, participants have the capacity to provide written informed consent and the ability to comply with all study procedures.
Who cannot join
- People expected to have abnormal vitamin B6 levels due to underlying conditions (renal disease, bowel disease, rheumatoid arthritis).
- People taking medications (other than levodopa) expected to interfere with B6 levels (steroids, cycloserine, hydralazine, isoniazid, theophylline, penicillamine).
Trial locations and contacts
1 site in 1 country.
United States1 site
Movement Disorders Clinic, University of Rochester Medical Center
Rochester, New York, 14618
About this study
Official title: A Cross-sectional Study of Serum Vitamin B6 Levels in People Living With Parkinson's Disease
The purpose of this study is to estimate the prevalence of abnormal serum levels of vitamin B6, and the associations of those levels with demographic and clinical variables in a randomly selected sample of people living with Parkinson's disease, compared to historical controls.
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's Disease, Vitamin B6
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People living with Parkinson's disease | 144 people living with Parkinson's disease randomly selected from a Movement Disorders Clinic in Rochester, NY, USA | |
| Historical controls | 144 matched controls from the National Health and Nutrition Examination Survey (NHANES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of vitamin B6 (Fasting)
nmol/L (log-transformed)
Measured: At enrollment
Secondary outcomes (30)
Age
Years
Measured: At enrollment
Sex
Female/Male
Measured: At enrollment
Race
As defined by the U.S. Office of Management and Budget: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White
Measured: At enrollment
Ethnicity
As defined by the U.S. Office of Management and Budget: Hispanic or Latino, non-Hispanic or Latino
Measured: At enrollment
Body mass index
kg/m2
Measured: At enrollment
Diabetes
Yes/No
Measured: At enrollment
Smoking
Yes/No
Measured: At enrollment
Alcohol use
Yes/No
Measured: At enrollment
Daily consumption of protein in the last 30 days
Yes/No
Measured: At enrollment
Daily consumption of food rich in B6 in the last 30 days
Yes/No
Measured: At enrollment
Food insecurity
Yes/No
Measured: At enrollment
Vitamin B6 supplement use in the last 30 days
Yes/No
Measured: At enrollment
Vitamin supplement use in the last 30 days
Yes/No
Measured: At enrollment
History of oral contraceptive pill use
Yes/No
Measured: At enrollment
Age at onset of Parkinson's disease
Years
Measured: At enrollment
Disease duration
Years
Measured: At enrollment
Disease stage
Hoehn and Yahr scale
Measured: At enrollment
Disease severity
Movement Disorders Society sponsored revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS): Total, Part I, Part II, Part III, and Part IV
Measured: At enrollment
Levodopa dosage
mg/day
Measured: At enrollment
Dosage of dopa decarboxylase inhibitor
mg/day
Measured: At enrollment
Levodopa/Carbidopa ratio
Measured: At enrollment
Cathecol-o-methyl-transferase inhibitor use
Yes/No
Measured: At enrollment
Dosage of cathecol-o-methyl-transferase inhibitor
mg/day
Measured: At enrollment
Levodopa equivalent daily dosage
mg/day
Measured: At enrollment
Polyneuropathy
modified Toronto Clinical Neuropathy Score
Measured: At enrollment
Epilepsy
Yes/No
Measured: At enrollment
Serum levels of vitamin B12 (Fasting)
pg/mL
Measured: At enrollment
Serum levels of homocysteine (Fasting)
µmol/L
Measured: At enrollment
Serum levels of methylmalonic acid (Fasting)
µmol/L
Measured: At enrollment
Serum levels of folic acid (Fasting)
ng/mL
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jul 2024
- Primary completion30 Jun 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karlo Lizarraga, University of Rochester
- Investigators
- Karlo J Lizarraga, MD, MS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430722
- Sponsor's protocol ID
- STUDY00009245
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wise A, Lemus HN, Fields M, Swan M, Bressman S. Refractory Seizures Secondary to Vitamin B6 Deficiency in Parkinson Disease: The Role of Carbidopa-Levodopa. Case Rep Neurol. 2022 Jun 27;14(2):291-295. doi: 10.1159/000525234. eCollection 2022 May-Aug.
PubMed 35949204Tardy AL, Pouteau E, Marquez D, Yilmaz C, Scholey A. Vitamins and Minerals for Energy, Fatigue and Cognition: A Narrative Review of the Biochemical and Clinical Evidence. Nutrients. 2020 Jan 16;12(1):228. doi: 10.3390/nu12010228.
PubMed 31963141Sardoeira A, Vila-Cha N, Corra M, Sousa AP, Maetzler W, Maia LF. Reply: Vitamins B6 and B12, levodopa, and their complex interactions in patients with Parkinson's disease. Brain. 2022 Sep 14;145(9):e79-e80. doi: 10.1093/brain/awac248. No abstract available.
PubMed 35802498Romagnolo A, Merola A, Artusi CA, Rizzone MG, Zibetti M, Lopiano L. Levodopa-Induced Neuropathy: A Systematic Review. Mov Disord Clin Pract. 2018 Nov 8;6(2):96-103. doi: 10.1002/mdc3.12688. eCollection 2019 Feb.
PubMed 30838307Rajabally YA, Martey J. Neuropathy in Parkinson disease: prevalence and determinants. Neurology. 2011 Nov 29;77(22):1947-50. doi: 10.1212/WNL.0b013e31823a0ee4. Epub 2011 Nov 2.
PubMed 22049200Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
PubMed 26474316Morris MS, Picciano MF, Jacques PF, Selhub J. Plasma pyridoxal 5'-phosphate in the US population: the National Health and Nutrition Examination Survey, 2003-2004. Am J Clin Nutr. 2008 May;87(5):1446-54. doi: 10.1093/ajcn/87.5.1446.
PubMed 18469270Modica JS, Dery C, Canissario R, Logigian E, Bonno D, Stanton M, Dupre N, McDermott MP, Bouchard M, Lang AE, Lizarraga KJ. A systematic review of the potential consequences of abnormal serum levels of vitamin B6 in people living with Parkinson's disease. J Neurol Sci. 2023 Jul 15;450:120690. doi: 10.1016/j.jns.2023.120690. Epub 2023 May 18.
PubMed 37210937Modica JS, Bonno D, Lizarraga KJ. Pearls and Oy-sters: Vitamin B6 deficiency presenting with new-onset epilepsy and status epilepticus in a patient with Parkinson disease. Neurology. 2020 Jun 16;94(24):e2605-e2607. doi: 10.1212/WNL.0000000000009647. Epub 2020 May 28. No abstract available.
PubMed 32467131Lizarraga KJ, Lang AE. Vitamins B6 and B12, levodopa, and their complex interactions in patients with Parkinson's disease. Brain. 2022 Sep 14;145(9):e77-e78. doi: 10.1093/brain/awac225. No abstract available.
PubMed 35802009Jameson HD. Pyridoxine for levodopa-induced dystonia. JAMA. 1970 Mar 9;211(10):1700. No abstract available.
PubMed 5467095Ghavanini AA, Kimpinski K. Revisiting the evidence for neuropathy caused by pyridoxine deficiency and excess. J Clin Neuromuscul Dis. 2014 Sep;16(1):25-31. doi: 10.1097/CND.0000000000000049.
PubMed 25137514Duvoisin RC, Yahr MD, Cote LD. Pyridoxine reversal of L-dopa effects in Parkinsonism. Trans Am Neurol Assoc. 1969;94:81-4. No abstract available.
PubMed 5374494Corra MF, Vila-Cha N, Sardoeira A, Hansen C, Sousa AP, Reis I, Sambayeta F, Damasio J, Calejo M, Schicketmueller A, Laranjinha I, Salgado P, Taipa R, Magalhaes R, Correia M, Maetzler W, Maia LF. Peripheral neuropathy in Parkinson's disease: prevalence and functional impact on gait and balance. Brain. 2023 Jan 5;146(1):225-236. doi: 10.1093/brain/awac026.
PubMed 35088837Canissario R, Stanton M, Modica JS, Logigian EL, Lizarraga KJ. Neuropathy due to coexistent vitamin B12 and B6 deficiencies in patients with Parkinson's disease: A case series. J Neurol Sci. 2021 Nov 15;430:120028. doi: 10.1016/j.jns.2021.120028. Epub 2021 Oct 12. No abstract available.
PubMed 34662813
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Serum Vitamin B6 Levels in People Living With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07430722
- Acronym / sponsor ID
- STUDY00009245
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's Disease, Vitamin B6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to estimate the prevalence of abnormal serum levels of vitamin B6, and the associations of those levels with demographic and clinical variables in a randomly selected sample of people living with Parkinson's disease, compared to historical controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with Parkinson's disease | – | –144 people living with Parkinson's disease randomly selected from a Movement Disorders Clinic in Rochester, NY, USA |
| Historical controls | – | –144 matched controls from the National Health and Nutrition Examination Survey (NHANES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Participants will be randomly selected from the people living with Parkinson's disease who are followed at the Movement Disorders Clinic at the University of Rochester in Rochester, NY, USA. * Matched historical controls will be randomly selected from the publicly available National Health and Nutrition Examination Survey.
Key inclusion criteria (4 listed)
- People with a clinical diagnosis of Parkinson's disease according to the diagnostic criteria of the Movement Disorders Society [Postuma 2015].
- Participants are ≥ 18 years old.
- As determined by the study investigators, participants are able to communicate at a level sufficient to undergo study interviews.
- As determined by the study investigators, participants have the capacity to provide written informed consent and the ability to comply with all study procedures.
Key exclusion criteria (2 listed)
- People expected to have abnormal vitamin B6 levels due to underlying conditions (renal disease, bowel disease, rheumatoid arthritis).
- People taking medications (other than levodopa) expected to interfere with B6 levels (steroids, cycloserine, hydralazine, isoniazid, theophylline, penicillamine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum levels of vitamin B6 (Fasting)
Time frame: At enrollment
nmol/L (log-transformed)
30 secondary outcomes
Age
Time frame: At enrollment
Sex
Time frame: At enrollment
Race
Time frame: At enrollment
Ethnicity
Time frame: At enrollment
Body mass index
Time frame: At enrollment
Diabetes
Time frame: At enrollment
Smoking
Time frame: At enrollment
Alcohol use
Time frame: At enrollment
Daily consumption of protein in the last 30 days
Time frame: At enrollment
Daily consumption of food rich in B6 in the last 30 days
Time frame: At enrollment
Food insecurity
Time frame: At enrollment
Vitamin B6 supplement use in the last 30 days
Time frame: At enrollment
Vitamin supplement use in the last 30 days
Time frame: At enrollment
History of oral contraceptive pill use
Time frame: At enrollment
Age at onset of Parkinson's disease
Time frame: At enrollment
Disease duration
Time frame: At enrollment
Disease stage
Time frame: At enrollment
Disease severity
Time frame: At enrollment
Levodopa dosage
Time frame: At enrollment
Dosage of dopa decarboxylase inhibitor
Time frame: At enrollment
Levodopa/Carbidopa ratio
Time frame: At enrollment
Cathecol-o-methyl-transferase inhibitor use
Time frame: At enrollment
Dosage of cathecol-o-methyl-transferase inhibitor
Time frame: At enrollment
Levodopa equivalent daily dosage
Time frame: At enrollment
Polyneuropathy
Time frame: At enrollment
Epilepsy
Time frame: At enrollment
Serum levels of vitamin B12 (Fasting)
Time frame: At enrollment
Serum levels of homocysteine (Fasting)
Time frame: At enrollment
Serum levels of methylmalonic acid (Fasting)
Time frame: At enrollment
Serum levels of folic acid (Fasting)
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 35949204Wise A, Lemus HN, Fields M, Swan M, Bressman S. Refractory Seizures Secondary to Vitamin B6 Deficiency in Parkinson Disease: The Role of Carbidopa-Levodopa. Case Rep Neurol. 2022 Jun 27;14(2):291-295. doi: 10.1159/000525234. eCollection 2022 May-Aug.
- Background: PubMed 31963141Tardy AL, Pouteau E, Marquez D, Yilmaz C, Scholey A. Vitamins and Minerals for Energy, Fatigue and Cognition: A Narrative Review of the Biochemical and Clinical Evidence. Nutrients. 2020 Jan 16;12(1):228. doi: 10.3390/nu12010228.
- Background: PubMed 35802498Sardoeira A, Vila-Cha N, Corra M, Sousa AP, Maetzler W, Maia LF. Reply: Vitamins B6 and B12, levodopa, and their complex interactions in patients with Parkinson's disease. Brain. 2022 Sep 14;145(9):e79-e80. doi: 10.1093/brain/awac248. No abstract available.
- Background: PubMed 30838307Romagnolo A, Merola A, Artusi CA, Rizzone MG, Zibetti M, Lopiano L. Levodopa-Induced Neuropathy: A Systematic Review. Mov Disord Clin Pract. 2018 Nov 8;6(2):96-103. doi: 10.1002/mdc3.12688. eCollection 2019 Feb.
- Background: PubMed 22049200Rajabally YA, Martey J. Neuropathy in Parkinson disease: prevalence and determinants. Neurology. 2011 Nov 29;77(22):1947-50. doi: 10.1212/WNL.0b013e31823a0ee4. Epub 2011 Nov 2.
- Background: PubMed 26474316Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
- Background: PubMed 18469270Morris MS, Picciano MF, Jacques PF, Selhub J. Plasma pyridoxal 5'-phosphate in the US population: the National Health and Nutrition Examination Survey, 2003-2004. Am J Clin Nutr. 2008 May;87(5):1446-54. doi: 10.1093/ajcn/87.5.1446.
- Background: PubMed 37210937Modica JS, Dery C, Canissario R, Logigian E, Bonno D, Stanton M, Dupre N, McDermott MP, Bouchard M, Lang AE, Lizarraga KJ. A systematic review of the potential consequences of abnormal serum levels of vitamin B6 in people living with Parkinson's disease. J Neurol Sci. 2023 Jul 15;450:120690. doi: 10.1016/j.jns.2023.120690. Epub 2023 May 18.
- Background: PubMed 32467131Modica JS, Bonno D, Lizarraga KJ. Pearls and Oy-sters: Vitamin B6 deficiency presenting with new-onset epilepsy and status epilepticus in a patient with Parkinson disease. Neurology. 2020 Jun 16;94(24):e2605-e2607. doi: 10.1212/WNL.0000000000009647. Epub 2020 May 28. No abstract available.
- Background: PubMed 35802009Lizarraga KJ, Lang AE. Vitamins B6 and B12, levodopa, and their complex interactions in patients with Parkinson's disease. Brain. 2022 Sep 14;145(9):e77-e78. doi: 10.1093/brain/awac225. No abstract available.
- Background: PubMed 5467095Jameson HD. Pyridoxine for levodopa-induced dystonia. JAMA. 1970 Mar 9;211(10):1700. No abstract available.
- Background: PubMed 25137514Ghavanini AA, Kimpinski K. Revisiting the evidence for neuropathy caused by pyridoxine deficiency and excess. J Clin Neuromuscul Dis. 2014 Sep;16(1):25-31. doi: 10.1097/CND.0000000000000049.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karlo J Lizarraga, MD, MS principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD), run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of vitamin B6 (Fasting) (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430722, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.