Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT injection have suboptimal zinc concentration in their tissues, and will experience improved response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a double blind placebo controlled cross-over study, randomized order placebo and OZS, in patients at a neurology clinic on stable dose of BoNT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
50 mg tablet
Zinc Acetate matched placebo tablet
Patient Global Impression of Change
Patient selects one of three options: My response to BoNT injection with bottle A tablets was overall better than with bottle B tablets; My response to BoNT injection with bottle B tablets was overall better than bottle A tablets; or Neither BoNT injection with bottle A or with bottle B tablets was overall better than the other
Time frame: End of study, week 48
Number of participants with treatment-related adverse events
Unstructured interview soliciting side-effects in the interval since prior BoNT injection
Time frame: At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.