Vitamin B 12 Deficiency
Conditions
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.
Interventions
DRUGCyanocobalamin
1,000 mg, Once
DRUGPlacebo
0.9% Sodium Chloride, Once
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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period * Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Singing Voice Handicap Index-10 (SVHI-10) - Change | Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection | 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always |
| Vocal Fold Swelling (Bastian et al., 2009) - Change | Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection | Happy Birthday, Staccato, Trill; 1 = Poor, 5 = Average, 10 = Excellent |
| Voice Fatigue Index (VFI) - Change | Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection | 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always |
| Evaluation of the Ability to Sing Easily (EASE) - Change | Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection | 1 = Not at All, 2 = Mildly, 3 = Moderately, 4 = Extremely |
| 0-10 Visual Analog Scale (VAS) - Change | Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Health Questionnaire-9 for Depression - Change | Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection | 0 = Not at All, 3 = Extremely |
| Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change | Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection | 1 = Not at All, 5 = Extremely |
Countries
United States
Outcome results
None listed