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ACTIVE NOT RECRUITING
NCT05892770
PHASE1/PHASE2

Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-08-01

Completion Date

2025-12

Last Updated

2025-02-25

Healthy Volunteers

Yes

Interventions

DRUG

Zinc gluconate supplement

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.

DRUG

Botulinum toxin type A

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.

Locations (1)

University of Florida- Shands Hospital

Gainesville, Florida, United States