Effects of Vitamin B12 Treatment in Singers

Vitamin B 12 Deficiency Clinical Trial

Official title:

Vitamin B12 Treatment in Singers - Assessment of Effects Exploratory Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437824
• Other study ID #: APP-16-06647
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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• Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

Drug:
• Cyanocobalamin
1,000 mg, Once
• Placebo
0.9% Sodium Chloride, Once

Locations

Country	Name	City	State
United States	Keck Medicine of USC - Downtown Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Ability to Sing Easily (EASE) - Change	1 = Not at All, 2 = Mildly, 3 = Moderately, 4 = Extremely	Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Primary	Singing Voice Handicap Index-10 (SVHI-10) - Change	0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always	Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Primary	0-10 Visual Analog Scale (VAS) - Change	The scale asks, "How confident are you that your voice will do what you need it to do right now?"; 0 = Not Confident At All, 10 = Extremely Confident	Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Primary	Vocal Fold Swelling (Bastian et al., 2009) - Change	Happy Birthday, Staccato, Trill; 1 = Poor, 5 = Average, 10 = Excellent	Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Primary	Voice Fatigue Index (VFI) - Change	0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always	Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Secondary	Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change	1 = Not at All, 5 = Extremely	Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Secondary	Patients Health Questionnaire-9 for Depression - Change	0 = Not at All, 3 = Extremely	Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection