Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05892770
Study type Interventional
Source University of Florida
Contact
Status Enrolling by invitation
Phase Phase 1/Phase 2
Start date August 1, 2023
Completion date May 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06111027 - Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia Phase 1/Phase 2
Withdrawn NCT02061943 - Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change N/A
Recruiting NCT05158166 - DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia Phase 1/Phase 2
Recruiting NCT05580302 - Cortical Silent Period in Laryngeal Dystonia
Recruiting NCT05150106 - Characterization of Clinical Phenotypes of Laryngeal Dystonia and Voice Tremor
Recruiting NCT05216770 - Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor Early Phase 1
Recruiting NCT05150093 - Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor N/A
Completed NCT00713414 - Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia
Completed NCT01961297 - Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response Phase 2
Completed NCT00118586 - Neuropathology of Spasmodic Dysphonia
Not yet recruiting NCT04938154 - A Phase 2 Trial of Deep Brain Stimulation for Spasmodic Dysphonia Phase 2
Active, not recruiting NCT03292458 - Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor Phase 2/Phase 3
Completed NCT02957942 - rTMS in Spasmodic Dysphonia N/A
Completed NCT02558634 - Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial N/A
Terminated NCT00895063 - Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia N/A
Completed NCT05158179 - Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia N/A
Not yet recruiting NCT06078527 - Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort N/A
Completed NCT04648891 - Spasmodic Dysphonia Pain Phase 2/Phase 3
Completed NCT03042962 - Brain Networks in Dystonia
Completed NCT03746509 - Laryngeal Vibration for Spasmodic Dysphonia N/A