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

This study has been terminated.
(lack of further funding)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Marian L. Evatt, Emory University
ClinicalTrials.gov Identifier:
NCT00208611
First received: September 13, 2005
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

This study examines the effects of supplementing patients who have Parkinson's disease with Vitamin B12.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:

U.S. FDA Resources

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
Estimated Study Completion Date: December 2020
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline
Experimental: vitamin B12 Drug: Vitamin B12 Supplementation
1000 micrograms daily
Other Name: vitamin B12
Dietary Supplement: Vitamin B12 supplement
1000 micrograms daily
Dietary Supplement: vitamin B12
1000 micrograms daily

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parkinson's disease or caregiver

Exclusion Criteria:

  • Not taking Vitamin B12 (multivitamin doses ok)
  • Atypical Parkinson's
  • Mini-Mental Status Score <25
  • Untreated thyroid or testosterone deficiency
  Contacts and Locations
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
National Institutes of Health (NIH)
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: EMORY IRB 178-2004
Study First Received: September 13, 2005
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on May 16, 2013