Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's Disease, Vitamin B6
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.
Interventions
None listed
Sponsors
University of Rochester
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of vitamin B6 (Fasting) | At enrollment | nmol/L (log-transformed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin supplement use in the last 30 days | At enrollment | Yes/No |
| History of oral contraceptive pill use | At enrollment | Yes/No |
| Age at onset of Parkinson's disease | At enrollment | Years |
| Disease duration | At enrollment | Years |
| Disease stage | At enrollment | Hoehn and Yahr scale |
| Disease severity | 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 |
| Levodopa dosage | At enrollment | mg/day |
| Dosage of dopa decarboxylase inhibitor | At enrollment | mg/day |
| Levodopa/Carbidopa ratio | At enrollment | — |
| Cathecol-o-methyl-transferase inhibitor use | At enrollment | Yes/No |
| Dosage of cathecol-o-methyl-transferase inhibitor | At enrollment | mg/day |
| Levodopa equivalent daily dosage | At enrollment | mg/day |
| Polyneuropathy | At enrollment | modified Toronto Clinical Neuropathy Score |
| Epilepsy | At enrollment | Yes/No |
| Serum levels of vitamin B12 (Fasting) | At enrollment | pg/mL |
| Serum levels of homocysteine (Fasting) | At enrollment | µmol/L |
| Serum levels of methylmalonic acid (Fasting) | At enrollment | µmol/L |
| Serum levels of folic acid (Fasting) | At enrollment | ng/mL |
| Age | At enrollment | Years |
| Sex | At enrollment | Female/Male |
| Race | 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 |
| Ethnicity | At enrollment | As defined by the U.S. Office of Management and Budget: Hispanic or Latino, non-Hispanic or Latino |
| Body mass index | At enrollment | kg/m2 |
| Diabetes | At enrollment | Yes/No |
| Smoking | At enrollment | Yes/No |
| Alcohol use | At enrollment | Yes/No |
| Daily consumption of protein in the last 30 days | At enrollment | Yes/No |
| Daily consumption of food rich in B6 in the last 30 days | At enrollment | Yes/No |
| Vitamin B6 supplement use in the last 30 days | At enrollment | Yes/No |
| Food insecurity | At enrollment | Yes/No |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKarlo J Lizarraga, MD, MS
University of Rochester
Outcome results
None listed