Recruiting
Phase 2

Zinc with Botox

Sponsor:

University of Florida

Code:

NCT07140874

Conditions

Cervical Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Zinc citrate

Placebo

Study Details

Brief 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.

Conditions

Cervical Dystonia

Study ID

NCT07140874

Start date

Jun 1, 2026

Status verified date

May, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Zinc citrate

Oral zinc citrate 30 mg daily

Placebo

Placebo

Primary outcome measure

  • Duration of Botox efficacy [ Time Frame: 3 and 6 months post intervention ]

Central Contacts and Locations

Central contacts

Julie Segura, BA

352-733-2412Julie.Segura@neurology.ufl.edu

Locations

Norman Fixel Institute for Neurological Diseases

Recruiting

Gainesville, Florida, United States, 32608

Principal Investigator:

Lauren Fanty, MD

More Information

Sponsor

University of Florida

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • cervical dystonia
  • botulinum toxin
  • Botox
  • zinc citrate
  • zinc

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-15.