NCT05095493

Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

Oral Zinc Supplementation to Enhance Effects of Botulinum Neurotoxin Injection: an n of 1 Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Months – 80 Years
• Healthy volunteers: Not accepted

Summary

Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT injection have suboptimal zinc concentration in their tissues, and will experience improved response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a double blind placebo controlled cross-over study, randomized order placebo and OZS, in patients at a neurology clinic on stable dose of BoNT.

Conditions

• Dystonia, Focal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc Acetate	50 mg tablet
DIETARY_SUPPLEMENT	Placebo	Zinc Acetate matched placebo tablet

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-10-31
• Completion: 2014-10-31
• First posted: 2021-10-27
• Last updated: 2021-10-27