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

NCT05911893 · tracked via the Priya Life Science China tracker

Sponsor

Children's Hospital of Chongqing Medical University

Phase

Not applicable

Started

2024-06-17

Last updated

2026-03-18

Condition(s) studied

Malnutrition, ChildMalnourishmentNutritional DeficiencyUndernutrition

Investigational drug(s) / intervention(s)

high caloric oral nutritional supplementsnutritional educationdietary guidance

high caloric oral nutritional supplements: 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.

nutritional education: After enrollment,health education information is pushed approximately every 4 weeks through the WeChat platform or/and short text messages to parents.

dietary guidance: 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.

Study 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

Sex

ALL

Min age

1 Year

Max age

3 Years

Healthy volunteers

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

Primary outcome measure(s)

BMI for Age Z-score(BAZ) — at 6 months of enrollment
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m\^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.

Trial sites (13)

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

More Children's Hospital of Chongqing Medical University trials in China

The Clinical Application Study of Obinutuzumab in Pediatric Refractory Nephrotic Syndrome Active, not recruiting

Hepatitis B Vaccination After Neonatal Surgery Recruiting

The Role of Biomarkers in the Occurrence and Development of Asthma Recruiting

Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet Recruiting

Design and Implementation of the Pediatric Liver Transplantation Biobank Recruiting

Other trials for the same condition

A Randomized, Double-blind, Placebo-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Sarcopenia With Silkworm Pupa Tablets in Patients With Malignancies Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05911893 on ClinicalTrials.gov ↗ ← All trials in China