Zinc as an Adjunctive Therapy for Cervical Dystonia

Официальное название

Evaluation of Supplemental Zinc as an Adjunct to Prolong the Duration of Benefit After Botulinum Toxin Injections in Subjects With Cervical Dystonia

Обзор

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.

Подробное описание

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 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 18-89 years. * Diagnosed with cervical dystonia. * Receiving regular BoNT type A (Botox) injections for at least six months.

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

Вмешательства

• Препарат Zinc citrate
  Oral zinc citrate 30 mg daily
• Препарат Placebo
  Placebo

Первичные конечные точки

• Duration of Botox efficacy [Срок оценки: 3 and 6 months post intervention]

Вторичные конечные точки (5)

• Change in Pain Severity [Срок оценки: 3 and 6 months post intervention]
• Change in Quality of Life [Срок оценки: 3 and 6 months post intervention]
• Change in Functional Disability [Срок оценки: 3 and 6 months post intervention]
• Patient Global Impression of Change [Срок оценки: 3 and 6 months post intervention]
• Clinician Global Impression of Change [Срок оценки: 3 and 6 months post intervention]

Критерии участия

Критерии включения

• Adults aged 18-89 years.
• Diagnosed with cervical dystonia.
• Receiving regular BoNT type A (Botox) injections for at least six months.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Norman Fixel Institute for Neurological Diseases — Gainesville

Публикации

• 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. PMID 30095365
• 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/ PMID 31613478
• 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. PMID 33950373
• Jeng SS, Chen YH. Association of Zinc with Anemia. Nutrients. 2022 Nov 20;14(22):4918. doi: 10.3390/nu14224918. PMID 36432604
• 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. PMID 37335837
• 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. PMID 22453589

Идентификаторы

NCT: NCT07140874 · IRB202500431

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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