Vitamin B 12 DeficiencyEarly Phase 1NCT03437824
Effects of Vitamin B12 Treatment in Singers
A Early Phase 1 study testing Cyanocobalamin in people with Vitamin B 12 Deficiency, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- Cyanocobalamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Apr 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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- Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of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))
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck Medicine of USC - Downtown Los Angeles
Los Angeles, California, 90017
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Cyanocobalamin, Placebo
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyanocobalaminDrug
Also called Vitamin B12
1,000 mg, Once
PlaceboDrug
Also called Normal Saline Solution
0.9% Sodium Chloride, Once
| Study group | Role | What they receive |
|---|---|---|
| Cyanocobalamin | Experimental | Vitamin B12, 1,000 mg, Once Receives: Drug: Cyanocobalamin |
| Placebo | Placebo comparator | Normal Saline Solution (0.9% Sodium Chloride), Once Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Ability to Sing Easily (EASE) - Change
1 = Not at All, 2 = Mildly, 3 = Moderately, 4 = Extremely
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
1 = Not at All, 5 = Extremely
Measured: 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
Measured: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Oct 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Johns, University of Southern California
- Investigators
- Hagit Shoffel-Havakuk, MD, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437824
- Sponsor's protocol ID
- APP-16-06647
- Status last verified
- Apr 2019
- First submitted
- 2 Jul 2017
- Last updated
- 9 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 33180098
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B12 Treatment in Singers - Assessment of Effects Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT03437824
- Acronym / sponsor ID
- APP-16-06647
- Conditions
- Vitamin B 12 Deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyanocobalamin | Experimental | Drug: CyanocobalaminVitamin B12, 1,000 mg, Once |
| Placebo | Placebo comparator | Drug: PlaceboNormal Saline Solution (0.9% Sodium Chloride), Once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyanocobalaminAlso: Vitamin B121,000 mg, Once | Drug | Cyanocobalamin |
| PlaceboAlso: Normal Saline Solution0.9% Sodium Chloride, Once | Drug | Placebo |
Primary outcome
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
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
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
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 33180098Shoffel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagit Shoffel-Havakuk, MD study director
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cyanocobalamin in people with Vitamin B 12 Deficiency, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03437824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.