A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms

What Was Tested

In this phase 1 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

For these indications the researchers are submitting INDs to the FDA as well as protocols to the IRB.

It had 1 arm (groups): Hydroxocobalamin (experimental).

The registry classes the interventions as drug.

More on the Plan

Flyers and emails will inform interested subjects of the trial and will assist with recruitment.

Patients may be identified by their physician or by a research coordinator with physician permission.

Patients identified by their healthcare providers who may meet entry criteria would be approached by a study team member to explain about the trial in more detail and to offer participation.

In collaboration with their physician, the patient will decide whether to consent and participate.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Ability to give consent.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: patients who are pregnant or breastfeeding; use of chronic medications; history of hypersensitivity to hydroxocobalamin.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

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

It started in 2023-01-02 with completion listed for 2023-06-30.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Adverse Events of Hydroxocobalamin Drug (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Cyanocobalamin (Vitamin B12) in 10 people.

Its size is small, so on its own it can only give an early look.

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.