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Effects of Vitamin B12 Treatment in Singers

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT03437824
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
18
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Vitamin B12 Treatment in Singers - Assessment of Effects Exploratory Pilot Study
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cyanocobalamin

Vitamin B12, 1,000 mg, Once

Drug: Cyanocobalamin
1,000 mg, Once
Other Names:
  • Vitamin B12

    		•
    Placebo Comparator: Placebo

    Normal Saline Solution (0.9% Sodium Chloride), Once

    Drug: Placebo
    0.9% Sodium Chloride, Once
    Other Names:
  • Normal Saline Solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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))

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keck Medicine of USC - Downtown Los Angeles Los Angeles California United States 90017

    Sponsors and Collaborators

    • University of Southern California

    Investigators

    • Study Director: Hagit Shoffel-Havakuk, MD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Johns, Principal Investigator, University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03437824
    Other Study ID Numbers:
    • APP-16-06647
    First Posted:
    Feb 19, 2018
    Last Update Posted:
    Apr 9, 2019
    Last Verified:
    Apr 1, 2019
    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
    Additional relevant MeSH terms:
    Vitamin B 12 Deficiency
    Vitamin B 12
    Hydroxocobalamin

    Study Results

    No Results Posted as of Apr 9, 2019