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

Recruiting now · Not applicable

Conditions studied: Malnutrition, Child, Malnourishment, Nutritional Deficiency, Undernutrition

In brief

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.

Key facts

Study ID

NCT05911893

Run by

Children's Hospital of Chongqing Medical University

People needed

200

Starts

2024-06-17

Expected to finish

2026-03-10

Last updated by the study team

2026-03-18

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Anhui Provincial Children's Hospital — Hefei, Anhui, China (enrolling)
• Children's Hospital of The Capital Institute of Pediatrics — Beijing, Beijing Municipality, China (enrolling)
• The First Hospital of Jilin University — Jilin City, Changchun, China (enrolling)
• Growth, Development and Mental health of Children and Adolescence Center — Chongqing, Chongqing Municipality, China (enrolling)
• Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (enrolling)
• Guiyang Maternity and Child Health Care Hospital — Guiyang, Guizhou, China (enrolling)
• Hunan Children's Hospital — Changsha, Hunan, China (enrolling)
• Nanjing Maternity and Child Health Care Hospital — Nanjing, Jiangsu, China (enrolling)
• Jiangxi Maternal and Child Health Hospital — Nanchang, Jiangxi, China (enrolling)
• Baoji Maternity and Child Healthcare Hospital — Baoji, Shanxi, China (enrolling)
• Xianyang Children's Hospital — Xianyang, Shanxi, China (enrolling)
• Chengdu Women's and Children's Central Hospital，School of Medicine，University of Electronic Science and Technology of China — Chengdu, Sichuan, China (enrolling)
• Kunming Children's Hospital — Kunming, Yunnan, China (enrolling)

Full record on ClinicalTrials.gov

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