Vitamin B6, B12, Folic Acid and Exercise in Parkinson's Disease

What Was Tested

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

The outcome variables will include: plasma homocysteine, GSH:GSSG ratio, cognitive function, balance, strength, functional activities, kinematic gait analysis, and a quality of life questionnaire.

It had four arms (groups): PD vitamin supplementation (experimental), PD exercise intervention (experimental), PD vitamin + exercise (experimental) and PD control (no intervention).

The registry classes the interventions as dietary supplement and other.

More on the Plan

Seventy percent of people with PD suffer from dementia or cognitive impairment.

Levodopa therapy, which is used to treat individuals with PD, causes elevated homocysteine levels (Blandini et al., 2001; Miller et al., 2003; Postuma \& Lang, 2004).

The mechanism behind the elevated homocysteine is related to vitamin B status (Miller et al., 2003; Postuma \& Lang, 2004).

L-dopa undergoes O-methylation and that reaction produces s-adenosylhomocysteine (SAH).

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 50 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Medical clearance to perform an exercise tolerance test and training program. A diagnosis of PD at stage 2 on the Hoehn and Yahr scale.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: A neurological condition other than PD/; anyone who is currently taking any vitamin supplementation; anyone currently engaged in weight training.

How the Study Was Run

The set-up was randomized, factorial and open-label.

The parkinson's disease participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the parkinson's disease participants and staff both knew the treatment.

It started in 2008-05 with completion listed for 2010-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Plasma homocysteine (time frame: 6 weeks). Plasma glutathione (GSH) (time frame: 6 weeks). Plasma glutathione disulfide (GSSG) (time frame: 6 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 40 people with parkinson's disease.

Its status is unknown; 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.