Adding zinc to Botox 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
This will test whether taking daily zinc citrate after a Botox injection helps people with cervical dystonia keep symptom relief longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07140874 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind, placebo-controlled crossover trial will enroll about 20 adults with cervical dystonia who already receive regular botulinum toxin type A injections at the University of Florida Movement Disorders Clinic. Participants will take zinc citrate 30 mg daily or matching placebo for three months after a scheduled Botox injection, then switch to the other treatment for another three months while keeping the same injection pattern. Outcomes include duration of symptom relief after injections, safety and tolerability measured by serum zinc, vitamin B12 and CBC, and patient-reported quality of life and functional measures. Clinic visits and blood draws occur every three months to coincide with routine Botox injections.
Who should consider this trial
Good fit: Adults aged 18–65 with diagnosed cervical dystonia who have been receiving regular Botox injections for at least one year and have a good response to treatment are ideal candidates.
Not a fit: Patients who do not respond to Botox, have a zinc allergy, are pregnant or breastfeeding, or already take high-dose zinc that would exceed safe limits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, patients might get longer-lasting relief from Botox and potentially need injections less often.
How similar studies have performed: Using zinc specifically to extend the benefit of botulinum toxin is largely novel and there is limited prior clinical evidence for this exact approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-65 years. * Diagnosed with cervical dystonia. * Receiving regular BoNT type A (Botox) injections for at least one year. 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.
Where this trial is running
Gainesville, Florida
- Norman Fixel Institute for Neurological Diseases — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Fanty, MD — University of Florida
- Study coordinator: Julie Segura, BA
- Email: Julie.Segura@neurology.ufl.edu
- Phone: 352-733-2412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.