Zinc as an Adjunctive Therapy for Cervical Dystonia
ConditionCervical Dystonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-89 years.
Diagnosed with cervical dystonia.
Receiving regular BoNT type A (Botox) injections for at least six months.
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Zinc citrate
DrugOral zinc citrate 30 mg daily
Placebo
DrugPlacebo
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Zinc firstExperimental treatment 2 interventions
Group B: Placebo firstExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
3 and 6 months post interventionSecondary outcomes
1
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.
Time frame
3 and 6 months post intervention2
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").
Time frame
3 and 6 months post intervention3
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.
Time frame
3 and 6 months post intervention4
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").
Time frame
3 and 6 months post interventionSponsors and contacts
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Source ClinicalTrials.gov