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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: Clinical Trial NA study, sponsored by Northwell Health.

NCT00853879 is a NA study that was terminated before completion, run by Northwell Health. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 150 participants
Start Date 2006-12
Est. Completion 2010-06
Phase NA
Northwell Health

370 total trials

Why NCT00853879 stopped before completion

NCT00853879 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 3 interventions - of which Folic Acid, Vitamin B6, Vitamin B12 is the first listed.

NCT00853879 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00853879's enrollment target sits among peer trials

150 661st of 2000 higher than 1,299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT00853879, the US trial registry maintained by the National Library of Medicine. NCT00853879 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.