Effectiveness and safety of low osmolar oral rehydration solution plus zinc (Electral-Z Plus) in patients with fever-induced dehydration– A pilot study

This is a prospective, observational, single-center, realworld study designed to evaluate the effectiveness and safety of a lowosmolar oral rehydration solution plus zinc (Electral Z Plus) in patients with fever induced dehydration. The study aims to assess improvement in dehydration symptoms and other clinical outcomes following treatment with Electral Z Plus compared to standard of care alone. The study hypothesis is that Electral Z Plus, when administered along with standard of care, will provide faster and more complete relief of dehydration symptoms in patients with fever-induced dehydration compared to standard of care alone.

The study will be conducted at one healthcare setup or clinic in India after obtaining Institutional Ethics Committee approval and written informed consent from all participants or their legally acceptable representatives. Separate informed consent documents are available for adults, parents or legal guardians, and adolescent participants.

A total of 60 patients aged 12 to 65 years with onset of fever within 72 hours and moderate dehydration based on the clinical dehydration scale will be enrolled. Patients will be divided in a 1 is to 1 ratio into two groups. Group I will receive standard-of-care plus Electral-Z Plus (n = 30, 15 pediatric and 15 adult patients), and Group II will receive standard-of-care alone (n = 30, 15 pediatric and 15 adult patients). Patients with onset of fever greater than three days, mild or severe dehydration, those on other oral rehydration salts or intravenous rehydration therapy, immunocompromised patients, or those with major chronic diseases or hypersensitivity to the study product will be excluded.

The study duration for each patient will be approximately 6 days plus or minus 2 days from baseline, with a follow up visit for clinical improvement and safety assessment. The overall study duration is expected to be about six to seven months.

The primary endpoint is the proportion of patients showing improvement in dehydration symptoms on the clinical dehydration scale at 6 days plus or minus 2 days from baseline. Secondary endpoints include complete resolution of dehydration symptoms, change in body weight, hospitalization rate, improvement in fever induced dehydration symptoms stratified by the number of tetra packs consumed, resolution of fever, mean change in body temperature, and frequency and severity of adverse events or serious adverse events.

All data will be captured using a structured data collection form and analyzed using R software. Continuous variables will be summarized as mean and standard deviation or median and range, and categorical variables as proportions. Statistical significance will be considered at p lesser than or equal to 0.05.