An Early Phase 1 interventional study of Cyanocobalamin and Placebo in Vitamin B 12 Deficiency, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by University of Southern California · Early Phase 1, Interventional, and Treatment
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.
73 studies on the registry are indexed under Vitamin B 12 Deficiency; 8 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 45 interventional studies indexed under Vitamin B 12 Deficiency.
Browse Vitamin B 12 Deficiency studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin B12, 1,000 mg, Once
Drug: Cyanocobalamin
Normal Saline Solution (0.9% Sodium Chloride), Once
Drug: Placebo
1,000 mg, Once
Also known as: Vitamin B12
0.9% Sodium Chloride, Once
Also known as: Normal Saline Solution
Evaluation of the Ability to Sing Easily (EASE) - Change
1 = Not at All, 2 = Mildly, 3 = Moderately, 4 = Extremely
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change
1 = Not at All, 5 = Extremely
Time frame: 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
Time frame: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin B 12
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