Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

NCT ID: NCT05892770

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Spasmodic Dysphonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botulinum toxin A injection

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.

Group Type: ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type: 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.

Botulinum toxin A injection +zinc supplementation"

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.

Group Type: EXPERIMENTAL

Zinc gluconate supplement

Intervention Type: 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.

Botulinum toxin type A

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

50 mg zinc gluconate (Puritan's Pride brand); Botox Type A

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Chheda

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida- Shands Hospital

Gainesville, Florida, United States

Countries

United States

Other Identifiers

OCR43808

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202202375

Identifier Type: -

Identifier Source: org_study_id