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NCT00853879 · ClinicalTrials.gov registry record · NA
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
A NA study, sponsored by Northwell Health.
- Terminated
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT00853879 is a NA study that was terminated before completion, run by Northwell Health. The registered enrollment target is 150 participants.
The verdict
NCT00853879, a NA study, was terminated before completion, sponsored by Northwell Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
This study is being conducted to assess the impact of folate and L-methylfolate on the progression of Parkinson's. The investigators are specifically looking for the effect of these nutritional supplements in Parkinson's patients who have an antibody that effects their body's utilization of folate. An antibody is a protein produced by the body's immune system to recognize foreign substances. Normally, people do not have an antibody that prevents folate from working properly in the brain but it appears that some people may have such an antibody. Folate is an important vitamin that takes part in many critical cell functions so an antibody that prevented it from entering the brain properly could cause or worsen certain neurological disorders like Parkinson's. The results of this preliminary study will help determine whether it is reasonable to proceed with further study of any of these supplements for the treatment of Parkinson's. Patients interested in participating will have a blood test to see if they have folate antibodies. Patients with the antibody will be eligible to further participate in the study. The investigators will measure the effects of folate and L-methylfolate on Parkinson's disease by measuring the change in your Parkinson's disease symptoms over three months of treatment. The investigators will also be looking at the blood of some individuals who do not have Parkinson's. This is called a control group and will allow us to compare how common the folate antibody is in the general population compared with the Parkinson's population.
Interventions
- DIETARY_SUPPLEMENT Folic Acid, Vitamin B6, Vitamin B12
- DIETARY_SUPPLEMENT B6, B12, L-methylfolate
- DIETARY_SUPPLEMENT B6, B12, Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00853879
The ClinicalTrials.gov registry entry for NCT00853879 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Folic Acid, Vitamin B6, Vitamin B12 is the first listed.
NCT00853879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00853879 about?
NCT00853879 is a clinical study titled "An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease". This study is being conducted to assess the impact of folate and L-methylfolate on the progression of Parkinson's. The investigators are specifically looking for the effect of these nutritional supplements in Parkinson's patients who have an antibody that effects their body's utilization of folate. ...
What is the current status of trial NCT00853879?
This trial is currently terminated. It is a NA study. The enrollment target is 150 participants. The study started on 2006-12. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00853879?
The interventions under investigation include: Folic Acid, Vitamin B6, Vitamin B12 (DIETARY_SUPPLEMENT), B6, B12, L-methylfolate (DIETARY_SUPPLEMENT), B6, B12, Placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00853879?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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