Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

NCT05892770 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB202202375OCR43808
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasmodic Dysphonia

Keywords

zinc; botox; botulinum toxin; spasmodic dysphonia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Study Arms (2)

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.

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.

Drug: Zinc gluconate supplement; Drug: Botulinum toxin type A

Interventions

Zinc gluconate supplement DRUG

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 known as: 50 mg zinc gluconate (Puritan's Pride brand)

Botulinum toxin A injection +zinc supplementation"

Botulinum toxin type A DRUG

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.

Also known as: Botox Type A

Botulinum toxin A injection; Botulinum toxin A injection +zinc supplementation"

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults patients
• years old and above
• Current diagnosis of ADductor spasmodic dysphonia
• Has had Botox injection treatments for SD \> 6 months

You may not qualify if:

• Pregnant
• Diagnosis of ABductor spasmodic dysphonia
• Patients taking \> 30 mg zinc supplementation daily prior to study beginning

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida- Shands Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Dysphonia

Interventions

gluconic acid; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Neil Chheda

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: June 7, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)