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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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