Effects of Vitamin B12 Treatment in Singers

What Was Tested

The trial (early phase 1) is built around Cyanocobalamin (Vitamin B12).

If so, they wish to examine the relationship between the vitamin B12 treatment and the study participant's general well-being.

It had two arms (groups): Cyanocobalamin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Consequently, some singers and voice professionals tend to ask for cobalamin injections in order to enhance their vocal performance.

However, there are no previous reports that illustrate the effects of vitamin B12 deficiency or treatment on voice performance.

Who Took Part

20 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: Aged 18 to 65 years old. An active singer who is presently singing. Willing and able to comply with the study requirements. Completed and signed an informed consent form.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: known vitamin b12 deficiency; active or recent vitamin b12 treatment (the subject must not receive vitamin b12 treatment for at least 4 weeks); any known bleeding disorder.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Cyanocobalamin (Vitamin B12) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

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

It started in 2017-10-01 with completion listed for 2019-04-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Evaluation of the Ability to Sing Easily (EASE) - Change (time frame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection). Singing Voice Handicap Index-10 (SVHI-10) - Change (time frame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection). 0-10 Visual Analog Scale (VAS) - Change (time frame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection).

It also tracked 2 secondary outcomes, for example Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change and Patients Health Questionnaire-9 for Depression - Change.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Cyanocobalamin (Vitamin B12) in 20 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.