Parkinson's Disease Clinical Trial
Official title:
Assessment of Cobalamin Status and Responses to Supplementation in Patients With Parkinson's Disease : a Pilot Study
Based on Parkinson's disease (PD)/vitamin B12 deficiency symptom overlap and PD patients'
propensity to avoid protein (the dietary source of vitamin B12), this study proposes to
prospectively investigate the vitamin B12 status of PD patients over time. In addition, this
study will provide critical pilot data evaluating the efficacy of treating those patients
considered to have below-normal vitamin B12 levels in serum. Further, it will also explore
the concept that supplementing PD patients having "low-normal" vitamin B12 levels with
vitamin B12 improves either the non-motor PD symptoms or homocysteine levels in PD patients
receiving levodopa.
Study Hypotheses:
1. Serum cobalamin (B12) concentrations in patients with Parkinson's disease (PD) are
significantly lower than B12 concentrations in a) cohabiting spousal caregiver
controls; and b) population-based, age-matched controls.
2. Supplementation with B12 in levodopa-treated PD patients with low (<200 pg/ml) or
low-normal (200-300 pg/ml) serum B12 levels is associated with significant improvement
in their non-motor symptoms and reduces total plasma homocysteine concentration [Hcy],
a known biomarker for risk of dementia and cerebrovascular disease.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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