Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Cyanocobalamin (Vitamin B12) for parkinson's disease.

Based on Parkinson's disease (PD)/vitamin B12 deficiency symptom overlap and PD patients' propensity to avoid protein (the dietary source of vitamin B12), this study proposes to prospectively investigate the vitamin B12 status of PD patients over time.

It had 1 arm (groups): Open-Label Treatment (experimental).

Levodopa-treated Parkinson's Disease subjects with vitamin B12 \< 200 pg/ml given oral vitamin B12 supplement.

The registry classes the interventions as dietary supplement.

Who Took Part

57 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: \>2 of cardinal signs/symptoms of Parkinson's disease (bradykinesia, tremor, rigidity). Cohabiting spousal caregivers (without Parkinson's disease) of patients enrolled in study are also eligible (but not required) to participate. Coexisting depression, if present, is stable. Males must have normal fasting testosterone levels (done at Screening visit or within 6 months of Screening Visit).

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: unstable medical conditions (terminal cancer, angina, etc) which could interfere with study assessments or put patient at risk for not completing the assessments; dopaminergic-unresponsive parkinsonism (i.e., patient has suspected multiple systems atrophy (msa), vascular or another form of parkinsonism); prior history of vitamin b12 deficiency or taking vitamin b12 supplements or injections (single multivitamin supplements are not an exclusion criteria).

How the Study Was Run

The set-up was single-group and quadruple-blind.

Blinding on both sides kept the parkinson's disease participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-09 with completion listed for 2010-02.

It ran at 1 site in United States.

What Was Measured

Primary outcome: Vitamin B12 concentration (time frame: Baseline).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Cyanocobalamin (Vitamin B12) in 57 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.