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

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12) for 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.

It had three arms (groups): Arm 1. B6, B12, folate (active comparator), Arm 2. B6, B12, L-methylfolate (active comparator) and Arm 3. B6, B12, Placebo (placebo comparator).

Triple therapy with folate. Intervention #1.

Triple therapy with L-methylfolate. Intervention #2.

Triple therapy with placebo. Intervention #3.

The registry classes the interventions as dietary supplement.

Who Took Part

150 actual participants took part.

It was open to people of any sex aged from 30 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: PD Subjects:; age \< 30; 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2006-12 with completion listed for 2010-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main 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 also tracked 1 secondary outcome, for example Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 150 people with parkinson's disease.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Parkinson's disease research.