the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Children's Hospital of Chongqing Medical University
200 participants
Jun 17, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to investigate the effect of high caloric oral nutritional supplements on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in participants aged 1 to 3 years who are malnourished (underweight and wasting),as well as to evaluate the safety of applying high caloric oral nutritional supplements. Participants will receive nutritional education and daily high caloric oral nutritional supplements(experimental group),or will receive nutritional education and dietary instruction(control group).This study may provide data to support the development of clinical intervention strategies for malnourished Chinese children.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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
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Interventions
High caloric oral nutritional supplements (which can supplement 30% of the energy requirement) is given daily, and the recommended amount of energy and protein is referred to the 2013 Chinese Dietary Nutrient Reference Intake Table. At 6 months of enrollment, participants will be asked to evaluate whether to continue feeding according to the experimental group protocol or to stop to ensure proper nutritional intake.
After enrollment,health education information is pushed approximately every 4 weeks through the WeChat platform or/and short text messages to parents.
At follow-up visits at 0, 1, 2, 3, 6,and 12 months after enrollment, a professionally trained pediatrician give the participant's guardian dietary instructions appropriate to the age stage and physical condition of the child. Each session lasts approximately 10 minutes.
Locations(13)
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NCT05911893