Zinc as an Adjunctive Therapy for Cervical Dystonia
NCT07140874 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-05-15
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
Interventions
- DRUG
-
Zinc citrate
Oral zinc citrate 30 mg daily
- DRUG
-
Placebo
Sponsors & Collaborators
-
University of Florida
lead OTHER
Principal Investigators
-
Lauren Fanty, MD · University of Florida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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