Trial Outcomes & Findings for Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia (NCT NCT05892770)
NCT ID: NCT05892770
Last Updated: 2026-07-27
Results Overview
10 question, validated survey to assess quality of voice of patients with spasmodic dysphonia. The overall V-RQOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
The patient will submit survey on post-injection day 2, 7, 14, 42, 70 and 98 (if next injection has not been performed).
Results posted on
2026-07-27
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin A Injection, Followed by Botulinum Toxin A Injection +Zinc Supplementation
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia. This is the current standard of care for treatment of this disease process. This will be the control of the study.
Botulinum toxin A injection: This is the current standard of care for treatment of spasmodic dysphonia. Botox injection goes into the vocal cord muscle, and will be occur in both the control and experimental arms of the study.
Other Names:
Botox Type A
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia, with subject taking zinc supplementation daily for the 5 days preceding the botox injection. This will be the experimental arm of the study.
Botulinum toxin A injection +zinc supplementation: Subjects will take a 50 mg zinc gluconate supplement at breakfast for the five days leading up to their next injection appointment. They will also answer questionnaires and provide audio recordings at various time points of the two injection cycles, which is roughly six months.
Other Names:
50 mg zinc gluconate (Puritan's Pride brand)
|
|---|---|
|
Botulinum Toxin A Injection
STARTED
|
32
|
|
Botulinum Toxin A Injection
COMPLETED
|
25
|
|
Botulinum Toxin A Injection
NOT COMPLETED
|
7
|
|
Botulinum Toxin A Injection +Zinc
STARTED
|
25
|
|
Botulinum Toxin A Injection +Zinc
COMPLETED
|
20
|
|
Botulinum Toxin A Injection +Zinc
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Botulinum Toxin A Injection, Followed by Botulinum Toxin A Injection +Zinc Supplementation
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia. This is the current standard of care for treatment of this disease process. This will be the control of the study.
Botulinum toxin A injection: This is the current standard of care for treatment of spasmodic dysphonia. Botox injection goes into the vocal cord muscle, and will be occur in both the control and experimental arms of the study.
Other Names:
Botox Type A
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia, with subject taking zinc supplementation daily for the 5 days preceding the botox injection. This will be the experimental arm of the study.
Botulinum toxin A injection +zinc supplementation: Subjects will take a 50 mg zinc gluconate supplement at breakfast for the five days leading up to their next injection appointment. They will also answer questionnaires and provide audio recordings at various time points of the two injection cycles, which is roughly six months.
Other Names:
50 mg zinc gluconate (Puritan's Pride brand)
|
|---|---|
|
Botulinum Toxin A Injection
Withdrawal by Subject
|
7
|
|
Botulinum Toxin A Injection +Zinc
Withdrawal by Subject
|
5
|
Baseline Characteristics
Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia
Baseline characteristics by cohort
| Measure |
Total Population Botulinum Toxin A Injection, Then Botulinum Toxin A + Zinc Supplementation
n=32 Participants
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia. This is the current standard of care for treatment of this disease process. This will be the control of the study.
Botulinum toxin type A: This is the current standard of care for treatment of spasmodic dysphonia. Botox injection goes into the vocal cord muscle, and will be occur in both the control and experimental arms of the study.
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia, with subject taking zinc supplementation daily for the 5 days preceding the botox injection. This will be the experimental arm of the study.
Zinc gluconate supplement: Subjects will take a 50 mg zinc gluconate supplement at breakfast for the five days leading up to their next injection appointment. They will also answer questionnaires and provide audio recordings at various time points of the two injection cycles, which is roughly six months.
Botulinum toxin type A: This is the current standard of care for treatment of spasmodic dysphonia. Botox injection goes into the vocal cord muscle, and will be occur in both the control and experimental arms of the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: The patient will submit survey on post-injection day 2, 7, 14, 42, 70 and 98 (if next injection has not been performed).Population: Based on V-RQOL score
10 question, validated survey to assess quality of voice of patients with spasmodic dysphonia. The overall V-RQOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor.
Outcome measures
| Measure |
Botulinum Toxin A Injection
n=32 Participants
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia. This is the current standard of care for treatment of this disease process. This will be the control of the study.
Botulinum toxin type A: This is the current standard of care for treatment of spasmodic dysphonia. Botox injection goes into the vocal cord muscle, and will be occur in both the control and experimental arms of the study.
|
Botulinum Toxin A Injection +Zinc Supplementation"
n=25 Participants
Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia, with subject taking zinc supplementation daily for the 5 days preceding the botox injection. This will be the experimental arm of the study.
Zinc gluconate supplement: Subjects will take a 50 mg zinc gluconate supplement at breakfast for the five days leading up to their next injection appointment. They will also answer questionnaires and provide audio recordings at various time points of the two injection cycles, which is roughly six months.
Botulinum toxin type A: This is the current standard of care for treatment of spasmodic dysphonia. Botox injection goes into the vocal cord muscle, and will be occur in both the control and experimental arms of the study.
|
|---|---|---|
|
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
Day 98
|
28.7 score on a scale
Standard Deviation 7.7
|
29.5 score on a scale
Standard Deviation 8.7
|
|
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
Day 2
|
29.9 score on a scale
Standard Deviation 8.8
|
26.1 score on a scale
Standard Deviation 9.6
|
|
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
Day 7
|
31.9 score on a scale
Standard Deviation 8.0
|
27.9 score on a scale
Standard Deviation 10.2
|
|
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
Day 14
|
28.3 score on a scale
Standard Deviation 9.5
|
28 score on a scale
Standard Deviation 11.6
|
|
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
Day 42
|
26.6 score on a scale
Standard Deviation 9.2
|
26.6 score on a scale
Standard Deviation 9.3
|
|
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
Day 70
|
28.5 score on a scale
Standard Deviation 12.6
|
26.7 score on a scale
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: The patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. At their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98Population: Sound recordings were obtained at the various time points. An algorithm for analysis was not successfully developed and no analysis was performed
At various points in the study, each subject will be recorded saying the same scripted passage. After all subjects have completed both cycles, all of the accrued audio recordings will be analyzed using a computer algorithm developed by one of our authors that assesses the quality of speech, with the data time points being averaged. The proposed algorithm was not successfully developed. One of the major concerns during the development process was which Natural Language Processing metrics should be utilized to best measure Spasmodic Dysphonia speech changes. No analysis conducted.
Outcome measures
Outcome data not reported
Adverse Events
Botulinum Toxin A Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Botulinum Toxin A Injection +Zinc Supplementation"
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place