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

This study has been terminated.
(Funding ended and enrollment not completed within a certain time period)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marian L. Evatt, Emory University
ClinicalTrials.gov Identifier:
NCT00208611
First received: September 13, 2005
Last updated: December 16, 2014
Last verified: December 2014
  Purpose

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.

Condition Intervention Phase
Parkinson's Disease
Dietary Supplement: Vitamin B12 Supplementation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Assessment of Cobalamin Status and Responses to Supplementation in Patients With Parkinson's Disease : a Pilot Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Vitamin B12 concentration [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: vitamin B12

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208611

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Marian L Evatt, MD Emory University
  More Information

No publications provided

Responsible Party: Marian L. Evatt, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00208611     History of Changes
Other Study ID Numbers: IRB00045854
Study First Received: September 13, 2005
Last Updated: December 16, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2015