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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00208611
Recruitment Status : Terminated (Funding ended and enrollment not completed within a certain time period)
First Posted : September 21, 2005
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Marian L. Evatt, Emory University

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE September 2006
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Vitamin B12 concentration [ Time Frame: Baseline ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease
Official Title  ICMJE Assessment of Cobalamin Status and Responses to Supplementation in Patients With Parkinson's Disease : a Pilot Study
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Dietary Supplement: Vitamin B12 Supplementation
1000 micrograms daily
Other Name: vitamin B12
Study Arms  ICMJE Experimental: Open-Label Treatment
Levodopa-treated Parkinson's Disease subjects with vitamin B12 < 200 pg/ml given oral vitamin B12 supplement
Intervention: Dietary Supplement: Vitamin B12 Supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 30, 2012)
57
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00208611
Other Study ID Numbers  ICMJE IRB00045854
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marian L. Evatt, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Marian L Evatt, MD Emory University
PRS Account Emory University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP