RecruitingPhase 2NCT07140874

Zinc as an Adjunctive Therapy for Cervical Dystonia

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


Sponsor

University of Florida

Enrollment

25 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria3

  • Adults aged 18-89 years.
  • Diagnosed with cervical dystonia.
  • Receiving regular BoNT type A (Botox) injections for at least six months.

Exclusion Criteria4

  • Known allergy or intolerance to zinc.
  • Significant comorbidities or concurrent medications that could interfere with study outcomes.
  • Pregnant or breastfeeding women.
  • Already taking a zinc supplement which would exceed tolerable upper intake level in adults (40 mg elemental zinc per day) with addition of zinc study supplement.

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Interventions

DRUGZinc citrate

Oral zinc citrate 30 mg daily

DRUGPlacebo

Placebo


Locations(1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

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NCT07140874


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