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

NCT ID: NCT00208611

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Open-Label Treatment

Levodopa-treated Parkinson's Disease subjects with vitamin B12 \< 200 pg/ml given oral vitamin B12 supplement

Group Type EXPERIMENTAL

Vitamin B12 Supplementation

Intervention Type DIETARY_SUPPLEMENT

1000 micrograms daily

Interventions

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Vitamin B12 Supplementation

1000 micrograms daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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vitamin B12

Eligibility Criteria

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Inclusion Criteria

* Patients seen in Emory Healthcare System at least once between 1/1/2002 and 05/31/2006 with idiopathic Parkinson's disease (defined as):
* \>2 of cardinal signs/symptoms of Parkinson's disease (bradykinesia, tremor, rigidity)
* \>50% improvement of symptoms when dopaminergic therapy started
* Cohabiting spousal caregivers (without Parkinson's disease) of patients enrolled in study are also eligible (but not required) to participate

* Coexisting depression, if present, is stable
* Normal thyroid screen (done at Screening Visit or at Emory Healthcare System within 3 months of Screening Visit)
* Males must have normal fasting testosterone levels (done at Screening visit or within 6 months of Screening Visit)

Exclusion Criteria

* Unstable medical conditions (terminal cancer, angina, etc) which could interfere with study assessments or put patient at risk for not completing the assessments.
* Dopaminergic-unresponsive parkinsonism (i.e., patient has suspected multiple systems atrophy (MSA), vascular or another form of parkinsonism)
* Untreated testosterone or thyroid abnormality
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Marian L. Evatt

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marian L Evatt, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00045854

Identifier Type: -

Identifier Source: org_study_id