Cervical DystoniaPhase 2NCT07140874
Zinc as an Adjunctive Therapy for Cervical Dystonia
A Phase 2 study testing Zinc citrate in people with Cervical Dystonia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Zinc citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-89 years.
- Diagnosed with cervical dystonia.
- Receiving regular BoNT type A (Botox) injections for at least six months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
Lauren Fanty, MD
Anastasia Barnes, MD
About this study
Official title: Evaluation of Supplemental Zinc as an Adjunct to Prolong the Duration of Benefit After Botulinum Toxin Injections in Subjects With Cervical Dystonia
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:
Read more
- 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.
- To assess the safety and tolerability of zinc supplementation in this patient population.
- 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.
Read the detailed 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 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
- Conditions
- Cervical Dystonia
- Being tested
- Zinc citrate, Placebo
- Keywords
- cervical dystonia, botulinum toxin, Botox, zinc citrate, zinc
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc citrateDrug
Oral zinc citrate 30 mg daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Zinc first | Experimental | Encapsulated zinc citrate 30 mg orally daily for 3 months followed by placebo capsule matching zinc daily for 3 months Receives: 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 Receives: Drug: Zinc citrate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 6 months post intervention
Secondary outcomes (5)
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.
Measured: 3 and 6 months post intervention
Change in Quality of Life
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").
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Fanty, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140874
- Sponsor's protocol ID
- IRB202500431
- Status last verified
- May 2026
- First submitted
- 15 Aug 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study researchers will be performing the analysis
Publications
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.
PubMed 30095365Rabinovich 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/
PubMed 31613478Shemais 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.
PubMed 33950373Jeng SS, Chen YH. Association of Zinc with Anemia. Nutrients. 2022 Nov 20;14(22):4918. doi: 10.3390/nu14224918.
PubMed 36432604Junior 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.
PubMed 37335837Koshy 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.
PubMed 22453589
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Supplemental Zinc as an Adjunct to Prolong the Duration of Benefit After Botulinum Toxin Injections in Subjects With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT07140874
- Acronym / sponsor ID
- IRB202500431
- Conditions
- Cervical Dystonia
- Keywords
- cervical dystonia, botulinum toxin, Botox, zinc citrate, zinc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To assess the safety and tolerability of zinc supplementation in this patient population.
- 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.
Detailed 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc first | Experimental | Drug: Zinc citrate, Drug: PlaceboEncapsulated zinc citrate 30 mg orally daily for 3 months followed by placebo capsule matching zinc daily for 3 months |
| Placebo first | Experimental | Drug: Zinc citrate, Drug: PlaceboPlacebo capsule matching zinc daily for 3 months, followed by encapsulated zinc citrate 30 mg orally daily for 3 months |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-89 years.
- Diagnosed with cervical dystonia.
- Receiving regular BoNT type A (Botox) injections for at least six months.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc citrateOral zinc citrate 30 mg daily | Drug | Placebo first, Zinc first |
| PlaceboPlacebo | Drug | Placebo first, Zinc first |
Primary outcome
Duration of Botox efficacy
Time frame: 3 and 6 months post intervention
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.
5 secondary outcomes
Change in Pain Severity
Time frame: 3 and 6 months post intervention
Change in Quality of Life
Time frame: 3 and 6 months post intervention
Change in Functional Disability
Time frame: 3 and 6 months post intervention
Patient Global Impression of Change
Time frame: 3 and 6 months post intervention
Clinician Global Impression of Change
Time frame: 3 and 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 30095365Betul 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.
- Background: PubMed 31613478Rabinovich 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/
- Background: PubMed 33950373Shemais 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.
- Background: PubMed 36432604Jeng SS, Chen YH. Association of Zinc with Anemia. Nutrients. 2022 Nov 20;14(22):4918. doi: 10.3390/nu14224918.
- BackgroundJunior 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.
- BackgroundXing 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: PubMed 37335837Mallat 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.
- Background: PubMed 22453589Koshy 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.
- Individual participant dataSharing planned: No. Study researchers will be performing the analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Fanty, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc citrate in people with Cervical Dystonia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Segura, BA (352-733-2412, Julie.Segura@neurology.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Botox efficacy (time frame: 3 and 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07140874, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.