Status:
TERMINATED
Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE2
PHASE3
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 investig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00208611
Start Date
September 1 2006
End Date
February 1 2010
Last Update
December 18 2014
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30329