Spasmodic DysphoniaPhase 1/2NCT05892770
Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia
A Phase 1/2 study testing Zinc gluconate supplement and Botulinum toxin type A in people with Spasmodic Dysphonia, run by University of Florida at 1 site in United States.
Trial summary
One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Spasmodic Dysphonia
- What is being tested?
- Zinc gluconate supplement and Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults patients
- 18 years old and above
- Current diagnosis of ADductor spasmodic dysphonia
- Has had Botox injection treatments for SD > 6 months
Who cannot join
- Pregnant
- Diagnosis of ABductor spasmodic dysphonia
- Patients taking > 30 mg zinc supplementation daily prior to study beginning
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida- Shands Hospital
Gainesville, Florida, 32610
About this study
Official title: The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia
One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. The purpose of the present study is to determine the effect, if any, of oral zinc supplementation prior to BT in the treatment of spasmodic dysphonia. If positive effects will be observed, this would help reduce the burden of disease for these patients.
Read the detailed description
Botulinum toxin (BT) injections are commonly used to treat various cosmetic, muscular, anesthetic, and neurologic pathologies. In 2012, one study suggested that a combination of zinc and phytase supplementation could increase the duration and degree of effects of botulinum neurotoxin type A (BoNTA). However, this study was met with scientific skepticism due to concerns of financial conflicts of interest, unmasking the study too early, and ambiguity of the dosage of zinc used. In 2021, a new study with 25 patients receiving BoNTA injections for the treatment of excessive gingival display (EGD), showed that zinc supplementation prolonged the effect of BoNTA with statistical significance. There has been no further studies or commentary since these latest results were published. The purpose of this study is to test if the effect of zinc supplementation on BoNTA can be replicated and also translated to a different disease process that is also treated with BT-spasmodic dysphonia (SD). If positive effects are discovered, this would strengthen the preliminary results of the 2021 study, encourage future larger studies on the same hypothesis, and, ultimately, could lead to reducing the burden of disease for patients with SD and any other condition that is treated with BT injections.
- Conditions
- Spasmodic Dysphonia
- Being tested
- Zinc gluconate supplement, Botulinum toxin type A
- Keywords
- zinc, botox, botulinum toxin, spasmodic dysphonia
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc gluconate supplementDrug
Also called 50 mg zinc gluconate (Puritan's Pride brand)
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.
Also called Botox 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.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A injection | Active comparator | 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. Receives: Drug: Botulinum toxin type A |
| Botulinum toxin A injection +zinc supplementation" | Experimental | 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. Receives: Drug: Zinc gluconate supplement; Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
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.
Measured: The patient will submit survey on post-injection day 2, 7, 14, 42, 70 and 98 (if next injection has not been performed).
Change in Audiometric Recording Data of Subject's Speech During a Laryngeal Botox Injection Cycle.
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.
Measured: 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 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spasmodic DysphoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Patient will be followed for one botox cycle as is current standard of care, and another botox cycle with the proposed intervention of zinc supplementation. Each patient will serve as their own control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Chheda, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892770
- Sponsor's protocol ID
- IRB202202375
- Other IDs
- OCR43808
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2023
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia
- ClinicalTrials.gov ID
- NCT05892770
- Acronym / sponsor ID
- IRB202202375
- Conditions
- Spasmodic Dysphonia
- Keywords
- zinc, botox, botulinum toxin, spasmodic dysphonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Posted 27 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. The purpose of the present study is to determine the effect, if any, of oral zinc supplementation prior to BT in the treatment of spasmodic dysphonia. If positive effects will be observed, this would help reduce the burden of disease for these patients.
Detailed description
Botulinum toxin (BT) injections are commonly used to treat various cosmetic, muscular, anesthetic, and neurologic pathologies. In 2012, one study suggested that a combination of zinc and phytase supplementation could increase the duration and degree of effects of botulinum neurotoxin type A (BoNTA). However, this study was met with scientific skepticism due to concerns of financial conflicts of interest, unmasking the study too early, and ambiguity of the dosage of zinc used. In 2021, a new study with 25 patients receiving BoNTA injections for the treatment of excessive gingival display (EGD), showed that zinc supplementation prolonged the effect of BoNTA with statistical significance. There has been no further studies or commentary since these latest results were published. The purpose of this study is to test if the effect of zinc supplementation on BoNTA can be replicated and also translated to a different disease process that is also treated with BT-spasmodic dysphonia (SD). If positive effects are discovered, this would strengthen the preliminary results of the 2021 study, encourage future larger studies on the same hypothesis, and, ultimately, could lead to reducing the burden of disease for patients with SD and any other condition that is treated with BT injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patient will be followed for one botox cycle as is current standard of care, and another botox cycle with the proposed intervention of zinc supplementation. Each patient will serve as their own control group.
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A injection | Active comparator | Drug: Botulinum toxin type ABotulinum 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 +zinc supplementation" | Experimental | Drug: Zinc gluconate supplement, Drug: Botulinum toxin type ABotulinum 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults patients
- 18 years old and above
- Current diagnosis of ADductor spasmodic dysphonia
- Has had Botox injection treatments for SD > 6 months
Key exclusion criteria (3 listed)
- Pregnant
- Diagnosis of ABductor spasmodic dysphonia
- Patients taking > 30 mg zinc supplementation daily prior to study beginning
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 |
|---|---|---|
| Zinc gluconate supplementAlso: 50 mg zinc gluconate (Puritan's Pride brand)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. | Drug | Botulinum toxin A injection +zinc supplementation" |
| Botulinum toxin type AAlso: Botox Type AThis 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. | Drug | Botulinum toxin A injection, Botulinum toxin A injection +zinc supplementation" |
Primary outcome
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.
Time frame: The patient will submit survey on post-injection day 2, 7, 14, 42, 70 and 98 (if next injection has not been performed).
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.
Change in Audiometric Recording Data of Subject's Speech During a Laryngeal Botox Injection Cycle.
Time frame: 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 98
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Neil Chheda principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zinc gluconate supplement and Botulinum toxin type A in people with Spasmodic Dysphonia, run by University of Florida 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 3 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 27 Jul 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle. (time frame: The patient will submit survey on post-injection day 2, 7, 14, 42, 70 and 98 (if next injection has not been performed).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.