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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:
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.
Study Design:
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.
Inclusion Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc first | Experimental | Encapsulated zinc citrate 30 mg orally daily for 3 months followed by placebo capsule matching zinc daily for 3 months |
|
| Placebo first | Experimental | Placebo capsule matching zinc daily for 3 months, followed by encapsulated zinc citrate 30 mg orally daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc citrate | Drug | Oral zinc citrate 30 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Botox efficacy | Time to return to baseline symptom severity using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale. The TWSTRS Severity Subscale is scored from 0 to 35, with higher numbers indicating a more severe condition. | 3 and 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Severity | Change in pain severity as measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale. The TWSTRS Pain Subscale is scored from 0 to 20, with higher numbers indicating a more painful condition. | 3 and 6 months post intervention |
| Change in Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Segura, BA | Contact | 352-733-2412 | Julie.Segura@neurology.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Fanty, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norman Fixel Institute for Neurological Diseases | Recruiting | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30095365 | Background | 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. | |
| 31613478 | Background | Rabinovich D, Smadi Y. Zinc. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547698/ |
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Study researchers will be performing the analysis
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Placebo |
| Drug |
Placebo |
|
Change in quality of life as measured by the Craniocervical dystonia questionnaire (CDQ-24). The CDQ-24 contains 24 items pertaining to quality of life in patients with cervical dystonia, scored from 0 ("never") to 4 ("very severely"). |
| 3 and 6 months post intervention |
| Change in Functional Disability | Change in functional disability as measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale. The TWSTRS Disability Subscale is scored from 0 to 30 with higher numbers indicating a more disabling condition. | 3 and 6 months post intervention |
| Patient Global Impression of Change | Patient Global Impression of Change (PGIC) measures the patient's perception of the change in their condition after treatment, scored from 1 ("Very much improved") to 7 ("Very much worse"). | 3 and 6 months post intervention |
| Clinician Global Impression of Change | The Clinician Global Impression of Change (CGIC) measures the researcher's perception of the change in the patient's condition after treatment, scored from 1 ("Very much improved") to 7 ("Very much worse"). | 3 and 6 months post intervention |
| 33950373 | Background | 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. |
| 36432604 | Background | Jeng SS, Chen YH. Association of Zinc with Anemia. Nutrients. 2022 Nov 20;14(22):4918. doi: 10.3390/nu14224918. |
| Background | 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. |
| Background | 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 |
| 37335837 | Background | 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. |
| 22453589 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |