Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

Not Applicable

Completed

• Conditions: Dystonia, Focal
• Interventions: Dietary Supplement: Zinc Acetate; Dietary Supplement: Placebo

• Registration Number: NCT05095493
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2014-10-31
• Study Completion: 2014-10-31
• Status Verified: 2021-10
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Study First Posted: 2021-10-27
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients of the PI
• Age 18-80
• Male or female
• With an approved indication for BoNT such as dystonia or hemifacial spasm
• Have received either two or three BoNT injection cycles within the prior 8 months
• Prior two injection cycles length differed by no more than 2 weeks
• Prior two injection cycles used same brand of BoNT and similar dose within 15%

Exclusion Criteria

• Concommitant use of penicillamine or cisplatin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
zinc, then placebo	Placebo	Participants first received oral zinc acetate 50 mg tab each day for 7 days before scheduled BoNT injection. 3 months later participants received oral placebo (matching oral zinc) tablet each day for 7 days before scheduled BoNT injection.
zinc, then placebo	Zinc Acetate	Participants first received oral zinc acetate 50 mg tab each day for 7 days before scheduled BoNT injection. 3 months later participants received oral placebo (matching oral zinc) tablet each day for 7 days before scheduled BoNT injection.
placebo, then zinc	Zinc Acetate	Participants first received placebo tablet (matching oral zinc) each day for 7 days before scheduled BoNT injection. 3 months later participants received oral zinc acetate 50 mg tablet each day for 7 days before scheduled BoNT injection.
placebo, then zinc	Placebo	Participants first received placebo tablet (matching oral zinc) each day for 7 days before scheduled BoNT injection. 3 months later participants received oral zinc acetate 50 mg tablet each day for 7 days before scheduled BoNT injection.

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Change	End of study, week 48	Patient selects one of three options: My response to BoNT injection with bottle A tablets was overall better than with bottle B tablets; My response to BoNT injection with bottle B tablets was overall better than bottle A tablets; or Neither BoNT injection with bottle A or with bottle B tablets was overall better than the other

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo	Unstructured interview soliciting side-effects in the interval since prior BoNT injection