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Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease

NCT00208611 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2014-12-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin B12 Supplementation

1000 micrograms daily

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Marian L Evatt, MD · Emory University

Study Design

Allocation
NA
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00208611 on ClinicalTrials.gov