Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
20 participants
INTERVENTIONAL
2017-10-01
2019-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Cyanocobalamin
Vitamin B12, 1,000 mg, Once
Cyanocobalamin
1,000 mg, Once
Placebo
Normal Saline Solution (0.9% Sodium Chloride), Once
Placebo
0.9% Sodium Chloride, Once
Interventions
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Cyanocobalamin
1,000 mg, Once
Placebo
0.9% Sodium Chloride, Once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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* Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))
18 Years
65 Years
ALL
Yes
Sponsors
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University of Southern California
OTHER
Responsible Party
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Michael Johns
Principal Investigator
Principal Investigators
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Hagit Shoffel-Havakuk, MD
Role: STUDY_DIRECTOR
University of Southern California
Locations
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Keck Medicine of USC - Downtown Los Angeles
Los Angeles, California, United States
Countries
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References
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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.
Other Identifiers
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APP-16-06647
Identifier Type: -
Identifier Source: org_study_id
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