High-calorie oral nutrition for growth and development in malnourished young children
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
This trial will test whether daily high-calorie oral nutritional supplements plus nutrition education help malnourished children aged 1–3 years gain more weight, grow taller, and improve development compared with nutrition education and dietary instruction alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Year to 3 Years |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 13 sites (Hefei, Anhui and 12 other locations) |
| Trial ID | NCT05911893 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, controlled trial enrolls children aged 1–3 years who are underweight or wasted and randomizes them to receive nutritional education plus daily high-calorie oral nutritional supplements (providing about 30% of energy needs) or to a control group receiving nutritional education and dietary instruction. Investigators will track body proportion, weight, linear growth patterns, neuropsychological development, gut health, immune function, quality of life, and safety outcomes over scheduled follow-up visits. Randomization uses a competitive entry method across participating pediatric centers in China, with regular monitoring of dietary intake and adverse events. The trial aims to generate data to guide clinical intervention strategies for malnourished Chinese children.
Who should consider this trial
Good fit: Children aged 1–3 years with BMI-for-age or height-for-age z-scores below -2, total daily energy intake under 75% of recommended intake, and whose guardians provide informed consent are ideal candidates.
Not a fit: Children with chronic severe infections, congenital or genetic conditions affecting growth, severe gastrointestinal disorders, allergies to the supplement ingredients, or those already receiving high-energy enteral nutrition are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could help undernourished toddlers gain weight, improve linear growth and developmental outcomes, and inform treatment guidelines for malnourished children in China.
How similar studies have performed: Some overseas studies have reported growth benefits from oral nutritional supplements in malnourished children, but no multicenter clinical trial in China has yet confirmed these results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hefei, Anhui and 12 other locations
- Anhui Provincial Children's Hospital — Hefei, Anhui, China (Recruiting)
- Children's Hospital of The Capital Institute of Pediatrics — Beijing, Beijing Municipality, China (Recruiting)
- The First Hospital of Jilin University — Jilin, Changchun, China (Recruiting)
- Growth, Development and Mental health of Children and Adolescence Center — Chongqing, Chongqing Municipality, China (Recruiting)
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (Recruiting)
- Guiyang Maternity and Child Health Care Hospital — Guiyang, Guizhou, China (Recruiting)
- Hunan Children's Hospital — Changsha, Hunan, China (Recruiting)
- Nanjing Maternity and Child Health Care Hospital — Nanjing, Jiangsu, China (Recruiting)
- Jiangxi Maternal and Child Health Hospital — Nanchang, Jiangxi, China (Recruiting)
- Baoji Maternity and Child Healthcare Hospital — Baoji, Shanxi, China (Recruiting)
- Xianyang Children's Hospital — Xianyang, Shanxi, China (Recruiting)
- Chengdu Women's and Children's Central Hospital，School of Medicine，University of Electronic Science and Technology of China — Chengdu, Sichuan, China (Recruiting)
- Kunming Children's Hospital — Kunming, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Li Chen, doctor
- Email: chenli2012@126.com
- Phone: 136 7762 0103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.