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

December 16, 2014 updated by: Marian L. Evatt, Emory University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)
  • Prior history of vitamin B12 deficiency or taking vitamin B12 supplements or injections (single multivitamin supplements are not an exclusion criteria)
  • Untreated testosterone or thyroid abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label Treatment
Levodopa-treated Parkinson's Disease subjects with vitamin B12 < 200 pg/ml given oral vitamin B12 supplement
Dietary supplement: Vitamin B12 Supplementation
1000 micrograms daily
Other Names:
  • vitamin B12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vitamin B12 concentration
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Marian L Evatt, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00045854

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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