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NCT Number: NCT05892770

Zinc Supplementation Prior to Botox Injections for 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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Florida- Shands Hospital

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 50 mg zinc gluconate (Puritan's Pride brand)

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.

Other names: Botox Type A

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 7, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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