Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

Last updated: February 24, 2025
Sponsor: University of Florida
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Speech Disorders

Dystonia

Treatment

Botulinum toxin type A

Zinc gluconate supplement

Clinical Study ID

NCT05892770
IRB202202375
OCR43808
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant

  • Diagnosis of ABductor spasmodic dysphonia

  • Patients taking > 30 mg zinc supplementation daily prior to study beginning

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Botulinum toxin type A
Phase: 1/2
Study Start date:
August 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Florida- Shands Hospital

    Gainesville, Florida 32610
    United States

    Site Not Available

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