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An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease

This study has been terminated.
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00853879
First received: February 26, 2009
Last updated: June 10, 2010
Last verified: June 2010

February 26, 2009
June 10, 2010
December 2006
December 2009   (final data collection date for primary outcome measure)
This study is being conducted to assess the impact of folate and L-methylfolate on the progression of Parkinson's. The primary endpoint variable will be the change in UPDRS from baseline to 3 months ("change score"). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00853879 on ClinicalTrials.gov Archive Site
Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
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. 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
  • Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12
    Intervention #1. A combination of the following vitamin supplements: 2.5mg of folate, 25mg of vitamin B6 and 2mg of vitamin B12. This combination will be described as "triple therapy with folate."
  • Dietary Supplement: B6, B12, L-methylfolate
    Intervention #2. A combination of the following vitamin supplements: 2.8mg of L-methylfolate, 25 mg of vitamin B6 and 2mg of vitamin B12.
  • Dietary Supplement: B6, B12, Placebo
    Intervention #3. A combination of the following vitamin supplements: 25mg of vitamin B6 and 2mg of vitamin B12 without supplementary folate or L-methylfolate. This combination will be described as "triple therapy with placebo"
  • Active Comparator: Arm 1. B6, B12, folate
    Triple therapy with folate. Intervention #1.
    Intervention: Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12
  • Active Comparator: Arm 2. B6, B12, L-methylfolate
    Triple therapy with L-methylfolate. Intervention #2
    Intervention: Dietary Supplement: B6, B12, L-methylfolate
  • Placebo Comparator: Arm 3. B6, B12, Placebo
    Triple therapy with placebo. Intervention #3.
    Intervention: Dietary Supplement: B6, B12, Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
260
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • PD subjects:

    • Diagnosis of Parkinson's based upon the presence of 2 or more of the cardinal clinical features of the disease as determined by a movement disorders specialist.
    • Age > 30.
    • Able to provide informed consent.
    • All anti-Parkinson's medications will be permitted but all evaluations will be done in the medication OFF state (at least 12 hours following the last dose of medication).
  • Healthy Controls *Age > 30

Exclusion Criteria:

  • PD Subjects:

    • Age < 30.
    • Presence of concomitant active neurological disorders as deemed significant by the investigator.
    • History of clinically significant diabetes, vascular disease, renal, thyroid or hepatic dysfunction or of Leber's optic neuropathy as determined by the investigator.
    • History of significant medical illness as determined by the investigators.
    • The following medications will be excluded: thiazide diuretics, azathioprine, phenytoin, phenobarbital, primidone, sulfa-containing medications, cimetidine, anti-tuberculosis medications, methotrexate, chemotherapeutic agents and oral contraceptives.
    • Subjects taking vitamin supplementation in excess of one daily standard multivitamin.
    • Pregnancy (excluded not for perceived risk but because most pregnant women are taking supplemental folate).
  • Healthy Controls:

    • Age < 30
    • Any known active neurological condition deemed significant by the investigator.
    • History of significant, active renal or hepatic dysfunction as determined by the investigator.
    • History of significant active medical illness as determined by the investigators.
    • The following medications will be excluded: thiazide diuretics, azathioprine, phenytoin, phenobarbital, primidone, sulfa-containing medications, cimetidine, anti-tuberculosis medications, methotrexate, chemotherapeutic agents and oral contraceptives.
    • Subjects taking vitamin supplementation in excess of one standard daily multivitamin.
    • Pregnancy (most pregnant women are taking folate).
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00853879
GCRC 0143
No
Michael Pourfar, MD, North Shore LIJ Health System
North Shore Long Island Jewish Health System
Not Provided
Principal Investigator: Michael Pourfar, MD North Shore-LIJ Health System
North Shore Long Island Jewish Health System
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP