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NCT00208611 · ClinicalTrials.gov registry record · Phase 2
Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00208611: Clinical Trial Phase 2 study, sponsored by Emory University.
NCT00208611 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00208611, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study 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 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.
Interventions
- DIETARY_SUPPLEMENT Vitamin B12 Supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
Why NCT00208611 stopped before completion
NCT00208611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin B12 Supplementation is the first listed.
NCT00208611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00208611 about?
NCT00208611 is a clinical study titled "Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease". 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 p...
What is the current status of trial NCT00208611?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2006-09. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00208611?
The interventions under investigation include: Vitamin B12 Supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00208611?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00208611's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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