NCT07430722

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

February 17, 2026

Last Update Submit

February 23, 2026

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's DiseaseVitamin B6

Outcome Measures

Primary Outcomes (1)

  • Serum levels of vitamin B6 (Fasting)

    nmol/L (log-transformed)

    At enrollment

Secondary Outcomes (30)

  • Age

    At enrollment

  • Sex

    At enrollment

  • Race

    At enrollment

  • Ethnicity

    At enrollment

  • Body mass index

    At enrollment

  • +25 more secondary outcomes

Other Outcomes (7)

  • Vitamin B6 supplementation

    Between enrollment and 6 months after enrollment

  • Dosage of vitamin B6 supplementation

    Between enrollment and 6 months after enrollment

  • Duration of vitamin B6 supplementation

    Between enrollment and 6 months after enrollment

  • +4 more other outcomes

Study Arms (2)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Movement Disorders Clinic, University of Rochester Medical Center

Rochester, New York, 14618, United States

Location

Related Publications (16)

  • 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.

    PMID: 35949204BACKGROUND

  • Tardy 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.

    PMID: 31963141BACKGROUND

  • Sardoeira 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.

    PMID: 35802498BACKGROUND

  • Romagnolo 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.

    PMID: 30838307BACKGROUND

  • Rajabally 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.

    PMID: 22049200BACKGROUND

  • Postuma 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.

    PMID: 26474316BACKGROUND

  • Morris 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.

    PMID: 18469270BACKGROUND

  • Modica 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.

    PMID: 37210937BACKGROUND

  • Modica 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.

    PMID: 32467131BACKGROUND

  • Lizarraga 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.

    PMID: 35802009BACKGROUND

  • Jameson HD. Pyridoxine for levodopa-induced dystonia. JAMA. 1970 Mar 9;211(10):1700. No abstract available.

    PMID: 5467095BACKGROUND

  • Ghavanini 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.

    PMID: 25137514BACKGROUND

  • Duvoisin RC, Yahr MD, Cote LD. Pyridoxine reversal of L-dopa effects in Parkinsonism. Trans Am Neurol Assoc. 1969;94:81-4. No abstract available.

    PMID: 5374494BACKGROUND

  • Corra 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.

    PMID: 35088837BACKGROUND

  • Canissario 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.

    PMID: 34662813BACKGROUND

  • Birnbaum AK, Leppik IE, Svensden K, Eberly LE. Prevalence of epilepsy/seizures as a comorbidity of neurologic disorders in nursing homes. Neurology. 2017 Feb 21;88(8):750-757. doi: 10.1212/WNL.0000000000003629. Epub 2017 Jan 20.

    PMID: 28108639BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Karlo J Lizarraga, MD, MS

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 24, 2026

Study Start

July 1, 2024

Primary Completion

June 30, 2025

Study Completion

February 15, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

US(1)