Clinical trial NCT03437824: Effects of Vitamin B12 Treatment in Singers
Official title: Vitamin B12 Treatment in Singers - Assessment of Effects Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vitamin B 12 Deficiency
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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* Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))

Primary outcomes:
measure: Evaluation of the Ability to Sing Easily (EASE) - Change
timeFrame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
measure: Singing Voice Handicap Index-10 (SVHI-10) - Change
timeFrame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
measure: 0-10 Visual Analog Scale (VAS) - Change
timeFrame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
measure: Vocal Fold Swelling (Bastian et al., 2009) - Change
timeFrame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
measure: Voice Fatigue Index (VFI) - Change
timeFrame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Secondary outcomes:
measure: Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change
timeFrame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
measure: Patients Health Questionnaire-9 for Depression - Change
timeFrame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medicine of USC - Downtown Los Angeles
state: California
Study officials:
affiliation: University of Southern California
name: Hagit Shoffel-Havakuk, MD
role: STUDY_DIRECTOR
References:
citation: Shoffel-Havakuk H, Lava CX, Reuven Y, Moog D, Odell K, Reder LS, Hapner ER, Johns MM 3rd. Effect of Vitamin B12 Injection on the Vocal Performance of Professional Singers: A Randomized, Double-blind, Placebo-Controlled, Crossover Trial. JAMA Otolaryngol Head Neck Surg. 2021 Jan 1;147(1):9-15. doi: 10.1001/jamaoto.2020.4026.