Study to Test the Safety and Effectiveness of Biolizin Zinc Supplement for Improving Poor Appetite in Children Aged 6 to 36 Months

What this Trial Is About

Poor appetite is common in young children and can affect their nutrient intake and eating behavior. This research aims to evaluate whether a zinc-containing oral supplement called Biolizin syrup can improve eating behavior in children aged 6 to 36 months who have poor appetite without a clear medical cause. The study is randomized and controlled, focusing on changes in feeding difficulty and eating behavior over 42 days. Children in the study receive either Biolizin syrup, taken once or twice daily according to age-based dosing for 42 days along with caregiver counseling on responsive feeding, or they receive only the caregiver counseling without the supplement. Caregivers attend clinic visits at Day 0, Day 7, Day 21, and Day 42 to receive counseling, report feeding behavior, and monitor adherence. Use of other zinc products or appetite stimulants is not allowed. Participants undergo measurements of weight and height at each visit, and caregivers complete validated questionnaires on feeding difficulties and eating behavior. Safety is monitored through adverse event review and laboratory tests at baseline and Day 42, including possible serum zinc levels. The main outcome measured is the change in feeding difficulty score from the start to Day 42. Secondary outcomes include changes in eating behavior subscales, growth indices, serum zinc, and overall safety throughout the study.

Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)