Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

University of Florida

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Spasmodic Dysphonia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05892770

IRB202202375

OCR43808 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Botulinum toxin A injection

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum toxin type A

Botulinum toxin A injection +zinc supplementation"

Experimental group

Description:

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.

Treatment:

Drug: Zinc gluconate supplement

Drug: Botulinum toxin type A