Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

Spasmodic Dysphonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05892770
• Other study ID #: IRB202202375
• Secondary ID: OCR43808
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: August 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Spasmodic Dysphonia

Intervention

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.
• 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

Country	Name	City	State
United States	University of Florida- Shands Hospital	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Voice-Related Quality of Life (V-RQOL) questionnaire scores during a laryngeal botox injection cycle.	10 question, validated questionnaire to assess quality of voice of patients with spasmodic dysphonia. The overall VR-QOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor.	The patient will submit survey on post-injection day 2, 7, 14, 42, 70, and 98. At their next botox injection, a second cycle will immediately begin for an additional 3 months with survey data obtained on post injection day 2, 7, 14, 42, 70, and 98
Primary	Change in audiometric recording data of subject's speech during a laryngeal botox injection cycle.	At various points in the study, each subject will be recorded saying the same scripted passage. After all subjects have completed both cycles, all of the accrued audio recordings will be analyzed using a computer algorithm developed by one of our authors that assesses the quality of speech.	The patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. At their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98