Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892770
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-18
First Post:
2023-04-26
Brief Title:
Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OCR43808 | OTHER | OnCore-UF | None |