Effects of Vitamin B12 Treatment in Singers

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin B 12 Deficiency
• Intervention / Treatment: Drug: Cyanocobalamin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90017
      • Keck Medicine of USC - Downtown Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: July 2, 2017
• First Submitted That Met QC Criteria: February 11, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Vitamin B 12 Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Vitamin B 12; Hydroxocobalamin
• Other Study ID Numbers: APP-16-06647

Drug and device information, study documents

• 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