Zinc for Wryneck

Overseen By Julie Segura, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must be taking: Botox

Disqualifiers: Zinc allergy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether zinc can extend the effects of Botox injections for individuals with cervical dystonia, a condition that causes neck muscles to tighten. Researchers aim to determine if zinc prolongs symptom relief and if it is safe and comfortable for participants. Participants will begin with either zinc or a placebo for three months and then switch. This trial suits those who have received regular Botox for neck dystonia for at least a year. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications that could interfere with the study, you might not be eligible to participate.

Is there any evidence suggesting that zinc supplementation is likely to be safe for humans?

Research has shown that zinc has been tested in people before, providing some insight into its safety. In previous studies, participants took zinc supplements, and no major safety issues emerged. This suggests zinc is generally safe for most people.

In this trial, participants will take zinc citrate daily for three months. Common side effects of zinc may include nausea or an upset stomach, but these are usually mild. This trial is in a middle stage, indicating that while zinc's safety has been studied, researchers are still learning more about its safety for this specific use.

Although evidence suggests zinc is safe, this trial will help determine how well zinc is tolerated when used with Botox for cervical dystonia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cervical dystonia?

Researchers are excited about using zinc for wryneck, a condition often treated with physical therapy and pain relief medications, because zinc offers a new approach. Unlike typical treatments that focus on symptom management, zinc aims to address the condition by potentially influencing muscle function and reducing inflammation due to its unique role as a trace element in the body. This could mean more targeted relief with fewer side effects, offering hope for a more effective and holistic approach to managing wryneck.

What evidence suggests that zinc supplementation could be effective for cervical dystonia?

This trial will compare zinc supplementation to a placebo in individuals with wryneck. Research has shown that zinc might extend the effects of Botox injections in people with cervical dystonia, a condition where neck muscles tighten uncontrollably. In a recent study, combining zinc with Botox improved the treatment's effectiveness and duration. Another study found that zinc supplements could prolong Botox's benefits. Early findings suggest zinc may enhance Botox's effectiveness and longevity for those with cervical dystonia. ^{1 2 6 7 8}

Who Is on the Research Team?

Adolfo Ramirez-Zamora, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals with cervical dystonia, also known as wryneck or torticollis, who are currently being treated with Botox injections at the University of Florida. Participants should be willing to take a daily supplement and attend regular clinic visits.

Inclusion Criteria

I have been diagnosed with cervical dystonia.

I have been getting Botox injections regularly for over a year.

I am between 18 and 65 years old.

Exclusion Criteria

Known allergy or intolerance to zinc

Pregnant or breastfeeding women

I don't have other major health issues or take medications that could affect the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive zinc citrate or placebo daily for 3 months, then cross over to the alternative treatment for another 3 months

6 months

Clinic visits every 3 months for Botox injections, check-ups, and surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Zinc

Trial Overview The study is testing whether taking zinc citrate supplements can make the symptom relief from Botox injections last longer for those with cervical dystonia. Patients will compare the effects of zinc against a placebo over two 3-month periods.

How Is the Trial Designed?

Group I: Zinc first Experimental Treatment 2 Interventions

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

Group II: Placebo first Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07140874

Zinc as an Adjunctive Therapy for Cervical Dystonia To analyze the potential influence of zinc supplementation on the quality of life and functional outcomes in cervical dystonia patients receiving Botox.

2. withpower.com withpower.com/trial/phase-2-torticollis-8-2025-83b96

Zinc for Wryneck · Info for Participants Trial Overview The study is testing whether taking zinc citrate supplements can make the symptom relief from Botox injections last longer for those with ...

3. neurology.org neurology.org/doi/10.1212/WNL.84.14_supplement.P4.330

Does Oral Zinc Supplementation Augment the Effect of ... A recent double-blinded pilot study reported that OZS with 50mg zinc citrate in combination with 3000 PU phytase prior to BoNT injection substantially enhanced ...

4. researchgate.net researchgate.net/publication/221978566_Effect_of_Dietary_Zinc_and_Phytase_Supplementation_on_Botulinum_Toxin_Treatments

Effect of Dietary Zinc and Phytase Supplementation on ... This study suggests a potentially meaningful role for zinc and/or phytase supplementation in increasing the degree and duration of botulinum toxin effect.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ana.78038?af=R

2025 CNS Meeting Abstract - 2025 - Annals of Neurology Data cutoff was 01Aug2024. RESULTS: In the efficacy set (n=27), UX111 led to a rapid and sustained reduction in CSF HS exposure relative to ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16470158/

Congenital muscular torticollis: current concepts and ... The purpose of this review is to better understand the spectrum of disease in torticollis, which is the third most common pediatric orthopaedic diagnosis in ...

7. oregon.gov oregon.gov/oha/HSD/OHP/Tools/Oregon%20Medicaid%20PA%20Criteria%20May%201,%202022.pdf

Oregon Medicaid PA Criteria May 1, 2022. ... safety and efficacy data. No: Pass to RPh. Request updated testing. 5. Which regimen is requested? Document and go to #6. 6. Does the patient ...

8. s3.amazonaws.com s3.amazonaws.com/ctr-gsk-7381/111981/b8d889b9-3d0a-4902-ade8-ba1c06f7221d/44801bd9-32ad-47e8-ae90-4558c9443e86/gsk-111981-clinical-study-report-redact-v1.pdf

gsk-111981-clinical-study-report- ... The primary objective of this study is to estimate the risk of dyskinesias and impulse control disorders amongst individuals prescribed the ...