Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease
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|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
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.
- 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.
- 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 or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Dietary Supplement: Vitamin B12 Supplementation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Assessment of Cobalamin Status and Responses to Supplementation in Patients With Parkinson's Disease : a Pilot Study|
|Study Start Date :||September 2006|
|Primary Completion Date :||February 2010|
|Study Completion Date :||February 2010|
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
- Vitamin B12 concentration [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208611
|United States, Georgia|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Marian L Evatt, MD||Emory University|