Effect of High Caloric Oral Nutritional Supplements on Growth and Development in Malnourished Children Aged 1 to 3 Years

What this Trial Is About

Researchers are evaluating the effects of high caloric oral nutritional supplements on growth, development, and related health aspects in malnourished children aged 1 to 3 years. This study aims to assess body proportion, weight, linear growth, neuropsychological development, gut health, immune function, and quality of life, while also evaluating the safety of these supplements. The trial addresses a lack of multicenter clinical data on these supplements in malnourished Chinese children and seeks to provide evidence for clinical intervention strategies. Participants will be randomly assigned to one of two groups the experimental group receiving nutritional education plus daily high caloric oral nutritional supplements that provide 30% of energy needs, and the control group receiving nutritional education and dietary guidance only. The intervention lasts 12 months, with the supplement feeding reviewed at 6 months to decide on continuation. Nutritional education is delivered via WeChat or text messages, and dietary guidance is provided by pediatricians at regular follow-up visits. Throughout the study, participants will be followed at 0, 1, 2, 3, 6, and 12 months. Researchers will collect dietary diaries, physical measurements, developmental tests, quality of life questionnaires, gut health and infectious disease assessments, and laboratory tests including blood, urine, liver, and kidney function. The main outcome measured is the BMI for Age Z-score at 6 months. Safety and efficacy are monitored continuously to understand the impact of the supplement on growth and development in malnourished children.

the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children