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Completed

NCT Number: NCT07430722

Cross-sectional Study of Vitamin B6 in 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.

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Movement Disorders Clinic, University of Rochester Medical Center

Rochester, New York, 14618, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Serum levels of vitamin B6 (Fasting)

    Time frame: At enrollment

    nmol/L (log-transformed)

Secondary outcomes

  1. Age

    Time frame: At enrollment

    Years

  2. Sex

    Time frame: At enrollment

    Female/Male

  3. 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

  4. Ethnicity

    Time frame: At enrollment

    As defined by the U.S. Office of Management and Budget: Hispanic or Latino, non-Hispanic or Latino

  5. Body mass index

    Time frame: At enrollment

    kg/m2

  6. Diabetes

    Time frame: At enrollment

    Yes/No

  7. Smoking

    Time frame: At enrollment

    Yes/No

  8. Alcohol use

    Time frame: At enrollment

    Yes/No

  9. Daily consumption of protein in the last 30 days

    Time frame: At enrollment

    Yes/No

  10. Daily consumption of food rich in B6 in the last 30 days

    Time frame: At enrollment

    Yes/No

  11. Food insecurity

    Time frame: At enrollment

    Yes/No

  12. Vitamin B6 supplement use in the last 30 days

    Time frame: At enrollment

    Yes/No

  13. Vitamin supplement use in the last 30 days

    Time frame: At enrollment

    Yes/No

  14. History of oral contraceptive pill use

    Time frame: At enrollment

    Yes/No

  15. Age at onset of Parkinson's disease

    Time frame: At enrollment

    Years

  16. Disease duration

    Time frame: At enrollment

    Years

  17. Disease stage

    Time frame: At enrollment

    Hoehn and Yahr scale

  18. 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

  19. Levodopa dosage

    Time frame: At enrollment

    mg/day

  20. Dosage of dopa decarboxylase inhibitor

    Time frame: At enrollment

    mg/day

  21. Levodopa/Carbidopa ratio

    Time frame: At enrollment

  22. Cathecol-o-methyl-transferase inhibitor use

    Time frame: At enrollment

    Yes/No

  23. Dosage of cathecol-o-methyl-transferase inhibitor

    Time frame: At enrollment

    mg/day

  24. Levodopa equivalent daily dosage

    Time frame: At enrollment

    mg/day

  25. Polyneuropathy

    Time frame: At enrollment

    modified Toronto Clinical Neuropathy Score

  26. Epilepsy

    Time frame: At enrollment

    Yes/No

  27. Serum levels of vitamin B12 (Fasting)

    Time frame: At enrollment

    pg/mL

  28. Serum levels of homocysteine (Fasting)

    Time frame: At enrollment

    µmol/L

  29. Serum levels of methylmalonic acid (Fasting)

    Time frame: At enrollment

    µmol/L

  30. Serum levels of folic acid (Fasting)

    Time frame: At enrollment

    ng/mL

Other outcomes

  1. Vitamin B6 supplementation

    Time frame: Between enrollment and 6 months after enrollment

    Yes/No

  2. Dosage of vitamin B6 supplementation

    Time frame: Between enrollment and 6 months after enrollment

  3. Duration of vitamin B6 supplementation

    Time frame: Between enrollment and 6 months after enrollment

  4. Benefits of vitamin B6 supplementation

    Time frame: Between enrollment and 6 months after enrollment

  5. Side effects of vitamin B6 supplementation

    Time frame: Between enrollment and 6 months after enrollment

  6. Follow-up serum levels of vitamin B6

    Time frame: Between enrollment and 6 months after enrollment

  7. 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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Cross-sectional Study of Serum Vitamin B6 Levels in People Living With Parkinson's Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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