Effects of Vitamin B12 Treatment in Singers
- Conditions
- Vitamin B 12 Deficiency
- Interventions
- Drug: Placebo
- Registration Number
- NCT03437824
- Lead Sponsor
- University of Southern California
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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- Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Normal Saline Solution (0.9% Sodium Chloride), Once Cyanocobalamin Cyanocobalamin Vitamin B12, 1,000 mg, Once
- Primary Outcome Measures
Name Time Method 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
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
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
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Keck Medicine of USC - Downtown Los Angeles
🇺🇸Los Angeles, California, United States