- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892770
Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia
September 14, 2023 updated by: University of Florida
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
36
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida- Shands Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults patients
- 18 years old and above
- Current diagnosis of ADductor spasmodic dysphonia
- Has had Botox injection treatments for SD > 6 months
Exclusion Criteria:
- Pregnant
- Diagnosis of ABductor spasmodic dysphonia
- Patients taking > 30 mg zinc supplementation daily prior to study beginning
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Botulinum toxin A injection
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.
|
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:
|
Experimental: Botulinum toxin A injection +zinc supplementation"
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.
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Voice-Related Quality of Life (V-RQOL) questionnaire 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. At their next botox injection, a second cycle will immediately begin for an additional 3 months with survey data obtained on post injection day 2, 7, 14, 42, 70, and 98
|
10 question, validated questionnaire to assess quality of voice of patients with spasmodic dysphonia.
The overall VR-QOL 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.
|
The patient will submit survey 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 survey data obtained on post injection day 2, 7, 14, 42, 70, and 98
|
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.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Chheda, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
April 26, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 7, 2023
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Signs and Symptoms, Respiratory
- Laryngeal Diseases
- Voice Disorders
- Dysphonia
- Hoarseness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Trace Elements
- Micronutrients
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- Zinc
Other Study ID Numbers
- IRB202202375
- OCR43808 (Other Identifier: OnCore-UF)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spasmodic Dysphonia
-
University of California, San FranciscoRecruitingSpasmodic Dysphonia | Adductor Spasmodic Dysphonia | Voice DisordersUnited States
-
Kumamoto UniversityKyoto University; Hokkaido University Hospital; Yokohama City University HospitalCompletedAdductor Spasmodic DysphoniaJapan
-
University of Wisconsin, MadisonCompleted
-
University of California, San FranciscoNational Spasmodic Dysphonia AssociationCompletedSpasmodic Dysphonia | Adductor Spasmodic Dysphonia | Voice DisordersUnited States
-
Lawson Health Research InstituteUnknownAdductor Spasmodic DysphoniaCanada
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingAdductor Spasmodic DysphoniaItaly
-
University of MinnesotaNot yet recruitingAdductor Spasmodic Dysphonia | Laryngeal Dystonia | Abductor Spastic DysphoniaUnited States
-
National Institute of Neurological Disorders and...Completed
-
Eastern Virginia Medical SchoolRecruitingDysphonia | Laryngeal Dystonia | Dysphonia, SpasticUnited States
-
University of British ColumbiaNot yet recruiting
Clinical Trials on Botulinum toxin type A
-
AllerganTerminatedOveractive BladderSerbia, Turkey, Greece, Egypt, Lebanon, India
-
Daewoong Pharmaceutical Co. LTD.Completed
-
AllerganCompletedOveractive BladderPortugal, South Africa, Netherlands, Canada, Singapore, Brazil, United States, Taiwan, Italy, United Kingdom, France, Spain
-
AllerganCompletedOveractive BladderUnited Kingdom, Belgium, New Zealand, France, Russian Federation, Czech Republic, United States, Germany, Austria, Poland, Slovakia, Ukraine, Canada, Australia
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar RhytidesUnited States
-
Brazilan Center for Studies in DermatologyCompletedWrinkles in Frontal AreaBrazil
-
HugelCompletedBenign Masseteric HypertrophyKorea, Republic of
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar Rhytides | Frown Lines Between the EyebrowsUnited States
-
Medy-ToxCompletedCervical Dystonia
-
Seton Healthcare FamilyCompleted