Cross-sectional Study of Vitamin B6 in Parkinson's Disease

February 23, 2026 updated by: Karlo Lizarraga, University of Rochester

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

288

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14618
        • Movement Disorders Clinic, University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of vitamin B6 (Fasting)
Time Frame: At enrollment
nmol/L (log-transformed)
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: At enrollment
Years
At enrollment
Sex
Time Frame: At enrollment
Female/Male
At enrollment
Race
Time Frame: At enrollment
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
Time Frame: At enrollment
As defined by the U.S. Office of Management and Budget: Hispanic or Latino, non-Hispanic or Latino
At enrollment
Body mass index
Time Frame: At enrollment
kg/m2
At enrollment
Diabetes
Time Frame: At enrollment
Yes/No
At enrollment
Smoking
Time Frame: At enrollment
Yes/No
At enrollment
Alcohol use
Time Frame: At enrollment
Yes/No
At enrollment
Daily consumption of protein in the last 30 days
Time Frame: At enrollment
Yes/No
At enrollment
Daily consumption of food rich in B6 in the last 30 days
Time Frame: At enrollment
Yes/No
At enrollment
Food insecurity
Time Frame: At enrollment
Yes/No
At enrollment
Vitamin B6 supplement use in the last 30 days
Time Frame: At enrollment
Yes/No
At enrollment
Vitamin supplement use in the last 30 days
Time Frame: At enrollment
Yes/No
At enrollment
History of oral contraceptive pill use
Time Frame: At enrollment
Yes/No
At enrollment
Age at onset of Parkinson's disease
Time Frame: At enrollment
Years
At enrollment
Disease duration
Time Frame: At enrollment
Years
At enrollment
Disease stage
Time Frame: At enrollment
Hoehn and Yahr scale
At enrollment
Disease severity
Time Frame: At enrollment
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
Time Frame: At enrollment
mg/day
At enrollment
Dosage of dopa decarboxylase inhibitor
Time Frame: At enrollment
mg/day
At enrollment
Levodopa/Carbidopa ratio
Time Frame: At enrollment
At enrollment
Cathecol-o-methyl-transferase inhibitor use
Time Frame: At enrollment
Yes/No
At enrollment
Dosage of cathecol-o-methyl-transferase inhibitor
Time Frame: At enrollment
mg/day
At enrollment
Levodopa equivalent daily dosage
Time Frame: At enrollment
mg/day
At enrollment
Polyneuropathy
Time Frame: At enrollment
modified Toronto Clinical Neuropathy Score
At enrollment
Epilepsy
Time Frame: At enrollment
Yes/No
At enrollment
Serum levels of vitamin B12 (Fasting)
Time Frame: At enrollment
pg/mL
At enrollment
Serum levels of homocysteine (Fasting)
Time Frame: At enrollment
µmol/L
At enrollment
Serum levels of methylmalonic acid (Fasting)
Time Frame: At enrollment
µmol/L
At enrollment
Serum levels of folic acid (Fasting)
Time Frame: At enrollment
ng/mL
At enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin B6 supplementation
Time Frame: Between enrollment and 6 months after enrollment
Yes/No
Between enrollment and 6 months after enrollment
Dosage of vitamin B6 supplementation
Time Frame: Between enrollment and 6 months after enrollment
Between enrollment and 6 months after enrollment
Duration of vitamin B6 supplementation
Time Frame: Between enrollment and 6 months after enrollment
Between enrollment and 6 months after enrollment
Benefits of vitamin B6 supplementation
Time Frame: Between enrollment and 6 months after enrollment
Between enrollment and 6 months after enrollment
Side effects of vitamin B6 supplementation
Time Frame: Between enrollment and 6 months after enrollment
Between enrollment and 6 months after enrollment
Follow-up serum levels of vitamin B6
Time Frame: Between enrollment and 6 months after enrollment
Between enrollment and 6 months after enrollment
Movement Disorders Society sponsored revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part IV
Time Frame: Between enrollment and 6 months after enrollment
Between enrollment and 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Karlo J Lizarraga, MD, MS, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

February 15, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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