Table of Contents
- Trial overview
- Who was studied
- What the trial tested
- Trial phase and design
- Outcomes measured
- Study status and size
Trial overview
The available trial of Zinc Acetate Dihydrate was a prospective pilot study called ZINCGNAO1, designed to address the feasibility and safety of oral zinc treatment in people with GNAO1 associated disorders.[1]
This was an interventional study, which means the researchers actively gave the treatment and then observed what happened.[1]
Who was studied
The target population was patients affected by GNAO1 associated disorders.[1]
The trial enrolled 12 participants.[1]
What the trial tested
The study tested oral zinc therapy using Wilzin 50 mg hard capsules and Wilzin 25 mg hard capsules, both given in a total planned dose of 150 mg by mouth, nasogastric tube, or percutaneous endoscopic gastrostomy tube.[1]
In simple terms, the trial was checking whether this zinc treatment plan could be followed in real life for people with GNAO1 associated disorders.[1]
Trial phase and design
This study was a Phase 2 trial.[1]
Phase 2 studies usually look more closely at safety and early signs of benefit after earlier testing, although this source only states the phase and the study goals, not treatment benefit results.[1]
The study was completed.[1]
Outcomes measured
The main feasibility outcome was measured by the actual days on which zinc was taken in the correct dose.[1]
The study considered the treatment feasible if the planned dose was taken on at least 80% of the days.[1]
The main safety outcome was regular evaluation of adverse events, meaning unwanted medical problems recorded during the study.[1]
Study status and size
The trial status was completed.[1]
Because this was a small pilot trial with 12 participants, it was mainly meant to learn whether the study plan was practical and safe enough for future research.[1]
