Effects of Vitamin B12 Treatment in Singers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin B 12 Deficiency

Intervention / Treatment
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* Drug: Cyanocobalamin
* Drug: Placebo


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period Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyanocobalamin<br>Vitamin B12, 1,000 mg, Once | Drug: Cyanocobalamin<br>* 1,000 mg, Once<br>* Other names: Vitamin B12;|
| Placebo Comparator: Placebo<br>Normal Saline Solution (0.9% Sodium Chloride), Once | Drug: Placebo<br>* 0.9% Sodium Chloride, Once<br>* Other names: Normal Saline Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |