Evaluation of Supplemental Zinc as an Adjunct to Prolong the Duration of Benefit After Botulinum Toxin Injections in Subjects With Cervical Dystonia
University of Florida
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.
Description
Study Design: * Randomized, single-blind, crossover placebo-controlled trial. * Participants: Approximately 20 patients diagnosed with cervical dystonia and currently receiving botulinum toxin (BoNT) type A (Botox) injections at the University of Florida (UF) Movement Disorders Clinic with good response to treatment as determined by treating neurologist will be enrolled into this study. The investigators plan to screen 25 patients to allow for screen failures and withdrawals. * Intervention: Participants will be randomized to receive either zinc citrate 30 mg supplementation or placebo starti…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugZinc citrate
Oral zinc citrate 30 mg daily
- DrugPlacebo
Placebo
Location
- Norman Fixel Institute for Neurological DiseasesGainesville, Florida