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
  Purpose

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.


Condition Intervention
Parkinson's Disease
Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12
Dietary Supplement: B6, B12, L-methylfolate
Dietary Supplement: B6, B12, Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1. B6, B12, folate
Triple therapy with folate. Intervention #1.
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."
Active Comparator: Arm 2. B6, B12, L-methylfolate
Triple therapy with L-methylfolate. Intervention #2
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.
Placebo Comparator: Arm 3. B6, B12, Placebo
Triple therapy with placebo. Intervention #3.
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"

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853879

Locations
United States, New York
The Feinstein Institute For Medical Recearch
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Michael Pourfar, MD North Shore-LIJ Health System
  More Information

No publications provided

Responsible Party: Michael Pourfar, MD, North Shore LIJ Health System
ClinicalTrials.gov Identifier: NCT00853879     History of Changes
Other Study ID Numbers: GCRC 0143
Study First Received: February 26, 2009
Last Updated: June 10, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Folic Acid
Vitamin B Complex
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxine
Pyridoxal
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014