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Completed

NCT Number: NCT03437824

Effects of Vitamin B12 Treatment in Singers

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.

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Key information

Conditions

Vitamin B 12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Keck Medicine of USC - Downtown Los Angeles

Los Angeles, California, 90017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))

Treatment and study plan

cyanocobalamin

Drug

1,000 mg, Once

Other names: Vitamin B12

Placebo

Drug

0.9% Sodium Chloride, Once

Other names: Normal Saline Solution

Primary outcomes

  1. Evaluation of the Ability to Sing Easily (EASE) - Change

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Vitamin B12 Treatment in Singers - Assessment of Effects Exploratory Pilot Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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