Effects of Vitamin B12 Treatment in Singers
Primary Purpose
Vitamin B 12 Deficiency
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cyanocobalamin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin B 12 Deficiency
Eligibility Criteria
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- Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))
Sites / Locations
- Keck Medicine of USC - Downtown Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cyanocobalamin
Placebo
Arm Description
Vitamin B12, 1,000 mg, Once
Normal Saline Solution (0.9% Sodium Chloride), Once
Outcomes
Primary Outcome Measures
Evaluation of the Ability to Sing Easily (EASE) - Change
1 = Not at All, 2 = Mildly, 3 = Moderately, 4 = Extremely
Singing Voice Handicap Index-10 (SVHI-10) - Change
0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always
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
Vocal Fold Swelling (Bastian et al., 2009) - Change
Happy Birthday, Staccato, Trill; 1 = Poor, 5 = Average, 10 = Excellent
Voice Fatigue Index (VFI) - Change
0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always
Secondary Outcome Measures
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change
1 = Not at All, 5 = Extremely
Patients Health Questionnaire-9 for Depression - Change
0 = Not at All, 3 = Extremely
Full Information
NCT ID
NCT03437824
First Posted
July 2, 2017
Last Updated
April 5, 2019
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT03437824
Brief Title
Effects of Vitamin B12 Treatment in Singers
Official Title
Vitamin B12 Treatment in Singers - Assessment of Effects Exploratory Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B 12 Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyanocobalamin
Arm Type
Experimental
Arm Description
Vitamin B12, 1,000 mg, Once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline Solution (0.9% Sodium Chloride), Once
Intervention Type
Drug
Intervention Name(s)
Cyanocobalamin
Other Intervention Name(s)
Vitamin B12
Intervention Description
1,000 mg, Once
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline Solution
Intervention Description
0.9% Sodium Chloride, Once
Primary Outcome Measure Information:
Title
Evaluation of the Ability to Sing Easily (EASE) - Change
Description
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
Title
Singing Voice Handicap Index-10 (SVHI-10) - Change
Description
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
Title
0-10 Visual Analog Scale (VAS) - Change
Description
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
Title
Vocal Fold Swelling (Bastian et al., 2009) - Change
Description
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
Title
Voice Fatigue Index (VFI) - Change
Description
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
Secondary Outcome Measure Information:
Title
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change
Description
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
Title
Patients Health Questionnaire-9 for Depression - Change
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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))
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagit Shoffel-Havakuk, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Director
Facility Information:
Facility Name
Keck Medicine of USC - Downtown Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33180098
Citation
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.
Results Reference
derived
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Effects of Vitamin B12 Treatment in Singers
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