Back to resultsAn Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Folic Acid, Vitamin B6, Vitamin B12
B6, B12, L-methylfolate
B6, B12, Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility 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).
Sites / Locations
- The Feinstein Institute For Medical Recearch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1. B6, B12, folate
Arm 2. B6, B12, L-methylfolate
Arm 3. B6, B12, Placebo
Arm Description
Triple therapy with folate. Intervention #1.
Triple therapy with L-methylfolate. Intervention #2
Triple therapy with placebo. Intervention #3.
Outcomes
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").
Secondary Outcome Measures
Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00853879
Brief Title
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
Official Title
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1. B6, B12, folate
Arm Type
Active Comparator
Arm Description
Triple therapy with folate. Intervention #1.
Arm Title
Arm 2. B6, B12, L-methylfolate
Arm Type
Active Comparator
Arm Description
Triple therapy with L-methylfolate. Intervention #2
Arm Title
Arm 3. B6, B12, Placebo
Arm Type
Placebo Comparator
Arm Description
Triple therapy with placebo. Intervention #3.
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid, Vitamin B6, Vitamin B12
Intervention Description
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."
Intervention Type
Dietary Supplement
Intervention Name(s)
B6, B12, L-methylfolate
Intervention Description
Intervention #2. A combination of the following vitamin supplements: 2.8mg of L-methylfolate, 25 mg of vitamin B6 and 2mg of vitamin B12.
Intervention Type
Dietary Supplement
Intervention Name(s)
B6, B12, Placebo
Intervention Description
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"
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Pourfar, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Feinstein Institute For Medical Recearch
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
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