Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo

What Was Tested

In this phase 4 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had two arms (groups): Test combination (experimental) and Comparative medication (active comparator).

The registry classes the interventions as drug.

More on the Plan

The former lowers anxiety symptoms.

Its precursor, glutamic acid, is the amino acid found in greater concentration under free form in the CNS; it is closely related to brain metabolism and, in contrast to GABA, it is the main excitatory neurotransmitter; glutamic acid also has anxyolytic therapeutic properties.

Thiamine or vitamin B1 is a cofactor in the synthesis of acetylcholine, which plays a central role in the initiation and propagation of neural impulse in the CNS as well as it does in the skeletal and myocardial muscles.

Pyridoxine is essential for the proper functioning of the CNS (including at nausea and vomiting center).

Who Took Part

334 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Female study subjects must agree in using contraceptives during study period. Dated informed consent read, understood and undersigned.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: hypersensitivity to the drugs of the study; history of gallblader stones; history of gastric mucosa inflammation.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2021-11-22 with completion listed for 2023-03-31.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: motion sickness assessment questionnaire (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 334 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.