Clinical trial NCT05892770: Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia
Official title: The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Spasmodic Dysphonia
Keywords: zinc
botox
botulinum toxin
spasmodic dysphonia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patient will be followed for one botox cycle as is current standard of care, and another botox cycle with the proposed intervention of zinc supplementation. Each patient will serve as their own control group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Voice-Related Quality of Life (V-RQOL) questionnaire scores during a laryngeal botox injection cycle.
timeFrame: 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
measure: Change in audiometric recording data of subject's speech during a laryngeal botox injection cycle.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida- Shands Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Neil Chheda
role: PRINCIPAL_INVESTIGATOR
References: