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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorChildren's Hospital of Chongqing Medical University

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

200 Participants
are divided into 2 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