Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2026-01-20
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
NCT05095493
Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia
NCT01384214
Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia
NCT05892770
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
NCT00407030
Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
NCT01546805
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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 starting immediately after their scheduled BoNT injection for 3 months. At a follow up BoNT injection, they will receive the alternative treatment for another 3 months. The total observation period is 6 months. Standard time between BoNT injections is 3 months.
The UF Movement Disorders Clinic follows approximately 1,500 cervical dystonia patients a year. The investigators do not anticipate any recruitment challenges.
Participants will be recruited during neurology clinic appointments and screening clinic appointments.
* Patients will receive the same pattern of BoNT injections (muscle selection and dose) during the duration of the study.
* Blood serum levels of zinc and vitamin B12 and complete blood counts (CBCs) will be measured at baseline and at the end of the study. Participants will be sent to UF Health Medical lab for blood draws and sample collection.
* Written informed consent will be obtained from each participant before any study-specific procedures or assessments are performed.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zinc first
Encapsulated zinc citrate 30 mg orally daily for 3 months followed by placebo capsule matching zinc daily for 3 months
Zinc citrate
Oral zinc citrate 30 mg daily
Placebo
Placebo
Placebo first
Placebo capsule matching zinc daily for 3 months, followed by encapsulated zinc citrate 30 mg orally daily for 3 months
Zinc citrate
Oral zinc citrate 30 mg daily
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zinc citrate
Oral zinc citrate 30 mg daily
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with cervical dystonia.
* Receiving regular BoNT type A (Botox) injections for at least one year.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Florida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lauren Fanty, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Betul Ergul A, Turanoglu C, Karakukcu C, Guler Kazanci E, Altuner Torun Y. Increased vitamin B12 levels in children with zinc deficiency. Int J Vitam Nutr Res. 2017 Sep;87(5-6):247-252. doi: 10.1024/0300-9831/a000444. Epub 2018 Aug 10.
Rabinovich D, Smadi Y. Zinc. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547698/
Shemais N, Elarab AE, ElNahass H. The effect of botulinum toxin A in patients with excessive gingival display with and without zinc supplementation: randomized clinical trial. Clin Oral Investig. 2021 Nov;25(11):6403-6417. doi: 10.1007/s00784-021-03944-2. Epub 2021 May 5.
Jeng SS, Chen YH. Association of Zinc with Anemia. Nutrients. 2022 Nov 20;14(22):4918. doi: 10.3390/nu14224918.
Junior HT, dos Santos Melo C, Mendes RR et al. Effects of zinc supplementation on duration and action of botulinum toxin applied to face muscles: A systematic review of randomized clinical trials. Journal of Trace Elements and Minerals. 5. 100080. 10.1016/j.jtemin.2023.100080.
Xing Y, O'Suilleabhain P. Does Oral Zinc Supplementation Augment the Effect of Botulinum Neurotoxin in Dystonia? Neurology 2015;84(14 Supplement):P4.330. doi: 10.1212/WNL.84.14_supplement.P4.330
Mallat F, Kaikati J, Kechichian E. Botulinum Toxins and Zinc: From Theory to Practice-A Systematic Review. Clin Neuropharmacol. 2023 Jun 20. doi: 10.1097/WNF.0000000000000557. Online ahead of print.
Koshy JC, Sharabi SE, Feldman EM, Hollier LH Jr, Patrinely JR, Soparkar CN. Effect of dietary zinc and phytase supplementation on botulinum toxin treatments. J Drugs Dermatol. 2012 Apr;11(4):507-12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB202500431
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.