Effects of Vitamin B12 Treatment in Singers

NCT03437824 | Completed Early Phase 1 FDA Drug

• 1 other identifier: APP-16-06647
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin B 12 Deficiency

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Cyanocobalamin

EXPERIMENTAL

Vitamin B12, 1,000 mg, Once

Drug: Cyanocobalamin

Placebo

PLACEBO COMPARATOR

Normal Saline Solution (0.9% Sodium Chloride), Once

Drug: Placebo

Interventions

Cyanocobalamin DRUG

1,000 mg, Once

Also known as: Vitamin B12

Cyanocobalamin

Placebo DRUG

0.9% Sodium Chloride, Once

Also known as: Normal Saline Solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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))

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Medicine of USC - Downtown Los Angeles

Los Angeles, California, 90017, United States

Location

Related Publications (1)

• 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.

  PMID: 33180098 DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

Vitamin B 12; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hagit Shoffel-Havakuk, MD

  University of Southern California

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2017
• First Posted: February 19, 2018
• Study Start: October 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

US (1)