About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- high caloric oral nutritional supplements
- nutritional education
- dietary guidance
Treatment groups
Sponsors and collaborators
Children's Hospital of Chongqing Medical University
Lead sponsor
Anhui Provincial Children's Hospital
Collaborator
Baoji Maternity and Child Healthcare Hospital
Collaborator
Chengdu Women's and Children's Central Hospital
Collaborator
Guiyang Maternity and Child Health Care Hospital
Collaborator
Guangzhou Women and Children's Medical Center
Collaborator
Hunan Children's Hospital
Collaborator
Jiangxi Maternal and Child Health Hospital
Collaborator
Kunming Children's Hospital
Collaborator
Nanjing Maternity and Child Health Care Hospital
Collaborator
Children's Hospital of The Capital Institute of Pediatrics
Collaborator
Xianyang Children's Hospital
Collaborator
Nestle Health Science
Collaborator
The First Hospital of Jilin University
Collaborator