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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:
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
  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:


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
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: 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
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 November 25, 2014