Zinc as an Adjunctive Therapy for Cervical Dystonia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Florida

About this trial

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 criteria

Qualifiers

Adults aged 18-89 years.

Diagnosed with cervical dystonia.

Receiving regular BoNT type A (Botox) injections for at least six months.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Zinc citrate
  • Placebo

Treatment groups

25 Participants
are divided into 2 treatment groups

Sponsors and collaborators