Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

The University of Texas System (UT)

Status: Completed

Conditions: Dystonia, Focal

Treatments: Dietary Supplement: Zinc Acetate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05095493

STU-082021-075

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 months to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

zinc, then placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Zinc Acetate

placebo, then zinc

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Zinc Acetate