Zinc as an Adjunctive Therapy for Cervical Dystonia

NCT07140874 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB202500431
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To assess the safety and tolerability of zinc supplementation in this patient population.
3. 3.To analyze the potential influence of zinc supplementation on the quality of life and functional outcomes in cervical dystonia patients receiving Botox.

Conditions

Cervical Dystonia

Keywords

cervical dystonia; botulinum toxin; Botox; zinc citrate; zinc

Outcome Measures

Primary Outcomes (1)

• 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 month post intervention

Secondary Outcomes (5)

• Change in Pain Severity at 3 months

  3 months post intervention

• Change in Quality of Life at 3 months

  3 months post intervention

• Change in Functional Disability at 3 months

  3 months post intervention

• Patient Global Impression of Change

  3 months post intervention

• Clinician Global Impression of Change

  3 months post intervention

Study Arms (2)

Zinc first

EXPERIMENTAL

Encapsulated zinc citrate 30 mg orally daily for 3 months followed by placebo capsule matching zinc daily for 3 months

Drug: Zinc citrate; Drug: Placebo

Placebo first

EXPERIMENTAL

Placebo capsule matching zinc daily for 3 months, followed by encapsulated zinc citrate 30 mg orally daily for 3 months

Drug: Zinc citrate; Drug: Placebo

Interventions

Zinc citrate DRUG

Oral zinc citrate 30 mg daily

Placebo first; Zinc first

Placebo DRUG

Placebo

Placebo first; Zinc first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years.
• Diagnosed with cervical dystonia.
• Receiving regular BoNT type A (Botox) injections for at least one year.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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/

  PMID: 31613478 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.

  PMID: 33950373 BACKGROUND

• Jeng SS, Chen YH. Association of Zinc with Anemia. Nutrients. 2022 Nov 20;14(22):4918. doi: 10.3390/nu14224918.

  PMID: 36432604 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

  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.

  PMID: 37335837 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.

  PMID: 22453589 BACKGROUND

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren Fanty, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Segura, BA

CONTACT

352-733-2412; Julie.Segura@neurology.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 26, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)