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

Launched by CHILDREN'S HOSPITAL OF CHONGQING MEDICAL UNIVERSITY · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how high-calorie oral nutritional supplements can help malnourished children aged 1 to 3 years. The goal is to see if these supplements can improve their growth, weight, and overall development, including their gut health and immune function. Children in the study will receive daily nutritional education and either the high-calorie supplements or just dietary guidance without the supplements. This research could help create better care strategies for malnourished children in China.

To participate, children must be between 1 and 3 years old and show signs of malnutrition, such as being underweight or having a low body mass index (BMI). Their guardians must also agree to join the study. Unfortunately, children with certain health conditions, like severe diseases or specific genetic disorders affecting growth, cannot take part. If eligible, participants will receive support and monitoring throughout the trial to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 1-3 years
• • BMI for Age Z-score\<-2
• • Height-for-age z score\<-2
• • Total daily energy intake\<75% of recommended nutrient intake
• • The child's guardian is willing to participate in this study and sign an informed consent form.
• Exclusion Criteria:
• • Chronic or severe infectious disease (e.g., chronic hepatitis, HIV or tuberculosis infection)
• • Certain congenital or genetic diseases affecting physical growth and development (congenital heart disease, Down's syndrome, infantile anorexia nervosa, etc.), malignancies and use of drugs (diuretics, appetite stimulants, steroids and growth hormones, etc.)
• • Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, inflammatory bowel disease, etc.)
• • Acute and chronic respiratory/digestive tract infections within 2 weeks prior to enrollment
• • Allergy or contraindication to any of the ingredients in the high-energy total nutrition formula used in this study
• • Have used high-energy enteral nutrition preparations for the last 3 months