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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyanocobalamin | Experimental | Vitamin B12, 1,000 mg, Once |
|
| Placebo | Placebo Comparator | Normal Saline Solution (0.9% Sodium Chloride), Once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanocobalamin | Drug | 1,000 mg, Once |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hagit Shoffel-Havakuk, MD | University of Southern California | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medicine of USC - Downtown Los Angeles | Los Angeles | California | 90017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33180098 | Derived | 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. |
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| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| Placebo | Drug | 0.9% Sodium Chloride, Once |
|
|
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 |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |