Status:
COMPLETED
Effects of Vitamin B12 Treatment in Singers
Lead Sponsor:
University of Southern California
Conditions:
Vitamin B 12 Deficiency
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 trea...
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, s...
Eligibility Criteria
Inclusion
- 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
- 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- Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03437824
Start Date
October 1 2017
End Date
April 1 2019
Last Update
April 9 2019
Active Locations (1)
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1
Keck Medicine of USC - Downtown Los Angeles
Los Angeles, California, United States, 90017