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Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

Primary Purpose

Spasmodic Dysphonia

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zinc gluconate supplement
Botulinum toxin type A
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasmodic Dysphonia focused on measuring zinc, botox, botulinum toxin, spasmodic dysphonia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Florida- Shands Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Botulinum toxin A injection

Botulinum toxin A injection +zinc supplementation"

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change of Voice-Related Quality of Life (V-RQOL) questionnaire scores during a laryngeal botox injection cycle.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2023
Last Updated
September 14, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05892770
Brief Title
Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia
Official Title
The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasmodic Dysphonia
Keywords
zinc, botox, botulinum toxin, spasmodic dysphonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin A injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Botulinum toxin A injection +zinc supplementation"
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zinc gluconate supplement
Other Intervention Name(s)
50 mg zinc gluconate (Puritan's Pride brand)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botox Type A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Voice-Related Quality of Life (V-RQOL) questionnaire scores during a laryngeal botox injection cycle.
Description
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.
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
Title
Change in audiometric recording data of subject's speech during a laryngeal botox injection cycle.
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Chheda
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida- Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

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