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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of vitamin B6 (Fasting) | nmol/L (log-transformed) | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Years | At enrollment |
| Sex | Female/Male | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin B6 supplementation | Yes/No | Between enrollment and 6 months after enrollment |
| Dosage of vitamin B6 supplementation | Between enrollment and 6 months after enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karlo J Lizarraga, MD, MS | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Movement Disorders Clinic, University of Rochester Medical Center | Rochester | New York | 14618 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35949204 | Background | 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. | |
| 31963141 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2025 | Feb 23, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 |
| At enrollment |
| Ethnicity | As defined by the U.S. Office of Management and Budget: Hispanic or Latino, non-Hispanic or Latino | At enrollment |
| Body mass index | kg/m2 | At enrollment |
| Diabetes | Yes/No | At enrollment |
| Smoking | Yes/No | At enrollment |
| Alcohol use | Yes/No | At enrollment |
| Daily consumption of protein in the last 30 days | Yes/No | At enrollment |
| Daily consumption of food rich in B6 in the last 30 days | Yes/No | At enrollment |
| Food insecurity | Yes/No | At enrollment |
| Vitamin B6 supplement use in the last 30 days | Yes/No | At enrollment |
| Vitamin supplement use in the last 30 days | Yes/No | At enrollment |
| History of oral contraceptive pill use | Yes/No | At enrollment |
| Age at onset of Parkinson's disease | Years | At enrollment |
| Disease duration | Years | At enrollment |
| Disease stage | Hoehn and Yahr scale | 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 | At enrollment |
| Levodopa dosage | mg/day | At enrollment |
| Dosage of dopa decarboxylase inhibitor | mg/day | At enrollment |
| Levodopa/Carbidopa ratio | At enrollment |
| Cathecol-o-methyl-transferase inhibitor use | Yes/No | At enrollment |
| Dosage of cathecol-o-methyl-transferase inhibitor | mg/day | At enrollment |
| Levodopa equivalent daily dosage | mg/day | At enrollment |
| Polyneuropathy | modified Toronto Clinical Neuropathy Score | At enrollment |
| Epilepsy | Yes/No | At enrollment |
| Serum levels of vitamin B12 (Fasting) | pg/mL | At enrollment |
| Serum levels of homocysteine (Fasting) | µmol/L | At enrollment |
| Serum levels of methylmalonic acid (Fasting) | µmol/L | At enrollment |
| Serum levels of folic acid (Fasting) | ng/mL | At enrollment |
| Duration of vitamin B6 supplementation | Between enrollment and 6 months after enrollment |
| Benefits of vitamin B6 supplementation | Between enrollment and 6 months after enrollment |
| Side effects of vitamin B6 supplementation | Between enrollment and 6 months after enrollment |
| Follow-up serum levels of vitamin B6 | Between enrollment and 6 months after enrollment |
| Movement Disorders Society sponsored revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part IV | Between enrollment and 6 months after enrollment |
| 35802498 | Background | 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. |
| 30838307 | Background | 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. |
| 22049200 | Background | 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. |
| 26474316 | Background | 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. |
| 18469270 | Background | 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. |
| 37210937 | Background | 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. |
| 32467131 | Background | 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. |
| 35802009 | Background | 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. |
| 5467095 | Background | Jameson HD. Pyridoxine for levodopa-induced dystonia. JAMA. 1970 Mar 9;211(10):1700. No abstract available. |
| 25137514 | Background | 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. |
| 5374494 | Background | 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. |
| 35088837 | Background | 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. |
| 34662813 | Background | 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. |
| 28108639 | Background | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |