Status:
TERMINATED
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
Lead Sponsor:
Northwell Health
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
NA
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 supple...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00853879
Start Date
December 1 2006
End Date
June 1 2010
Last Update
May 15 2015
Active Locations (1)
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1
The Feinstein Institute For Medical Recearch
Manhasset, New York, United States, 11030