Effects of Vitamin B12 Treatment in Singers

University of Southern California

Status and phase: Completed; Early Phase 1

Conditions: Vitamin B 12 Deficiency

Treatments: Drug: Placebo; Drug: Cyanocobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT03437824

APP-16-06647

Details and patient eligibility

About

In this study, the investigators aim to assess if vitamin B12 treatment demonstrates a beneficial effect on voice performance. If so, they wish to examine the relationship between the vitamin B12 treatment and the study participant's general well-being.

Full description

Through the investigators' experience, they have observed that amongst singers and voice professionals, there is a common belief that there are voice benefits from cobalamin treatment. 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Any known laryngeal pathology
• Plans to start any new treatment, oral/parenteral anticoagulant, supplement, or medication during the study period
• Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of the Ability to Sing Easily (EASE), and less than or equal to 4 in the Singing Voice Handicap Index 10 (SVHI-10))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Cyanocobalamin

Experimental group

Description:

Vitamin B12, 1,000 mg, Once

Treatment:

Drug: Cyanocobalamin

Placebo

Placebo Comparator group

Description:

Normal Saline Solution (0.9% Sodium Chloride), Once

Treatment:

Drug: Placebo