NCT07430722已完成不适用
A Cross-sectional Study of Serum Vitamin B6 Levels in People Living With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Serum levels of vitamin B6 (Fasting)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Historical controls
144 matched controls from the National Health and Nutrition Examination Survey (NHANES)
People living with Parkinson's disease
144 people living with Parkinson's disease randomly selected from a Movement Disorders Clinic in Rochester, NY, USA
结局指标
主要结局
Serum levels of vitamin B6 (Fasting)
时间窗: At enrollment
nmol/L (log-transformed)
次要结局
- Ethnicity(At enrollment)
- Body mass index(At enrollment)
- Diabetes(At enrollment)
- Smoking(At enrollment)
- Alcohol use(At enrollment)
- Daily consumption of protein in the last 30 days(At enrollment)
- Daily consumption of food rich in B6 in the last 30 days(At enrollment)
- Food insecurity(At enrollment)
- Vitamin B6 supplement use in the last 30 days(At enrollment)
- Vitamin supplement use in the last 30 days(At enrollment)
- History of oral contraceptive pill use(At enrollment)
- Age at onset of Parkinson's disease(At enrollment)
- Disease duration(At enrollment)
- Disease stage(At enrollment)
- Disease severity(At enrollment)
- Levodopa dosage(At enrollment)
- Dosage of dopa decarboxylase inhibitor(At enrollment)
- Levodopa/Carbidopa ratio(At enrollment)
- Cathecol-o-methyl-transferase inhibitor use(At enrollment)
- Dosage of cathecol-o-methyl-transferase inhibitor(At enrollment)
- Levodopa equivalent daily dosage(At enrollment)
- Polyneuropathy(At enrollment)
- Epilepsy(At enrollment)
- Serum levels of vitamin B12 (Fasting)(At enrollment)
- Serum levels of homocysteine (Fasting)(At enrollment)
- Serum levels of methylmalonic acid (Fasting)(At enrollment)
- Serum levels of folic acid (Fasting)(At enrollment)
- Age(At enrollment)
- Sex(At enrollment)
- Race(At enrollment)
研究者
Karlo Lizarraga
Associate Professor of Neurology
University of Rochester
研究点 (1)
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