Evaluation of Supplemental Zinc as an Adjunct to Prolong the Duration of Benefit After Botulinum Toxin Injections in Subjects With Cervical Dystonia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to evaluate if supplemental zinc can prolong the duration of benefit of botulinum toxin injections in cervical dystonia patients receiving care at the University of Florida. The main aims are: 1. To evaluate the efficacy of zinc citrate supplementation in prolonging the duration of symptom relief provided by botulinum toxin type A (Botox) injections in cervical dystonia patients. 2. To assess the safety and tolerability of zinc supplementation in this patient population. 3. To analyze the potential influence of zinc supplementation on the quality of life and functional outcomes in cervical dystonia patients receiving Botox. Researchers will compare zinc citrate to a placebo (a look-alike substance that contains no active drug) to see if zinc works to extend the effects of Botox. Participants will: Take zinc citrate or a placebo every day for 3 months, then cross over to the alternative treatment for another 3 months. Visit the clinic every 3 months for Botox injections, check ups and surveys.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adults aged 18-65 years.

• Diagnosed with cervical dystonia.

• Receiving regular BoNT type A (Botox) injections for at least one year.

Locations
United States
Florida
Norman Fixel Institute for Neurological Diseases
RECRUITING
Gainesville
Contact Information
Primary
Julie Segura, BA
Julie.Segura@neurology.ufl.edu
352-733-2412
Time Frame
Start Date: 2025-09-17
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 20
Treatments
Experimental: Zinc first
Encapsulated zinc citrate 30 mg orally daily for 3 months followed by placebo capsule matching zinc daily for 3 months
Experimental: Placebo first
Placebo capsule matching zinc daily for 3 months, followed by encapsulated zinc citrate 30 mg orally daily for 3 months
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov