Parkinson's DiseaseNCT00853879
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
A study testing Folic Acid, Vitamin B6, Vitamin B12 and B6, B12, L-methylfolate in people with Parkinson's Disease, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Folic Acid, Vitamin B6, Vitamin B12 and B6, B12, L-methylfolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Feinstein Institute For Medical Recearch
Manhasset, New York, 11030
About this study
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.
- Conditions
- Parkinson's Disease
- Being tested
- Folic Acid, Vitamin B6, Vitamin B12, B6, B12, L-methylfolate, B6, B12, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic Acid, Vitamin B6, Vitamin B12Dietary supplement
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."
B6, B12, L-methylfolateDietary supplement
Intervention #2. A combination of the following vitamin supplements: 2.8mg of L-methylfolate, 25 mg of vitamin B6 and 2mg of vitamin B12.
B6, B12, PlaceboDietary supplement
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"
| Study group | Role | What they receive |
|---|---|---|
| Arm 1. B6, B12, folate | Active comparator | Triple therapy with folate. Intervention #1. Receives: Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12 |
| Arm 2. B6, B12, L-methylfolate | Active comparator | Triple therapy with L-methylfolate. Intervention #2 Receives: Dietary Supplement: B6, B12, L-methylfolate |
| Arm 3. B6, B12, Placebo | Placebo comparator | Triple therapy with placebo. Intervention #3. Receives: Dietary Supplement: B6, B12, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 3 years
Secondary outcomes (1)
Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startDec 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Pourfar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853879
- Sponsor's protocol ID
- GCRC 0143
- Status last verified
- May 2015
- First submitted
- 26 Feb 2009
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00853879
- Acronym / sponsor ID
- GCRC 0143
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1. B6, B12, folate | Active comparator | Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12Triple therapy with folate. Intervention #1. |
| Arm 2. B6, B12, L-methylfolate | Active comparator | Dietary Supplement: B6, B12, L-methylfolateTriple therapy with L-methylfolate. Intervention #2 |
| Arm 3. B6, B12, Placebo | Placebo comparator | Dietary Supplement: B6, B12, PlaceboTriple therapy with placebo. Intervention #3. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PD subjects:
- Healthy Controls *Age > 30
Key exclusion criteria (16 listed)
- PD Subjects:
- Healthy Controls:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acid, Vitamin B6, Vitamin B12Intervention #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 | Arm 1. B6, B12, folate |
| B6, B12, L-methylfolateIntervention #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 | Arm 2. B6, B12, L-methylfolate |
| B6, B12, PlaceboIntervention #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" | Dietary supplement | Arm 3. B6, B12, Placebo |
Primary outcome
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
1 secondary outcome
Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels
Time frame: 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Pourfar, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid, Vitamin B6, Vitamin B12 and B6, B12, L-methylfolate in people with Parkinson's Disease, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.