New formulation zinc sulphate acceptability and adherence in children with acute diarrhoea: A prospective, open‐label, interventional study in Bangladesh

Abstract

Aim: Zinc is an adjunct to oral rehydration salts for management of diarrhoea in children. Due to zinc's unpleasant taste, children often develop nausea and/or vomiting. We aimed to assess acceptability (tolerability) and adherence of improvised formulation of zinc tablet among under-five children with acute diarrhoea. Methods: This was an open-label intervention trial among 3-59 months old diarrhoeal children attending the outpatient department of Dhaka Hospital, who were enrolled in two age strata, 3 to <18 months and 18-59 months. Zinc tablets 10 or 20 mg per day were prescribed for a total of 10 days for <6 months and ≥6 months age children respectively, with follow-up. Diary-cards were used to record events. Results: In stratum 1, 158 (90.8%) children and in stratum 2, 144 (95.4%) children completed the study as per protocol out of 325 enrolled children. Sociodemographic, clinical and anthropometric measurements were comparable in the two strata except admission diarrhoeal duration (median 3 days vs. 2 days, P = 0.001). Adherence to 10 days treatment was 123 (77.8%) in stratum 1 and 127 (88.2%) in stratum 2. Zinc tablets were tolerated very well/well in 280 (92.7%) children. Vomiting, regurgitation and nausea were observed in 99 (32.8%), 59 (19.5%) and 22 (7.4%) children respectively. Caregivers' willingness to use the same drug in future was 300 (99.3%) among all children. Conclusion: Our study findings demonstrate that modified taste and formulation zinc tablets were well tolerated, and caregivers' willingness to use this formulation in future supports its acceptability, adherence and palatability.

Nutritional Profiles and Zinc Supplementation among Children with Diarrhea in Bangladesh

“…For this study, data were extracted from the screening dataset of a clinical trial entitled "Zinc sulfate acceptability study in children with acute diarrhea: A prospective, open-label, interventional study" (ClinicalTrials.gov ID: NCT04039828). 18 This was a hospital-based study in which a total of 1,399 children aged 3-59 months were screened between September 2019 and March 2020. The children had been admitted between 8:30 AM and 5:00 pm to the OPD unit of Dhaka Hospital, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), for management of diarrheal illnesses.…”