Actively Recruiting

Phase Not Applicable
Age: 1Year - 3Years
All Genders
NCT05911893

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

Led by Children's Hospital of Chongqing Medical University · Updated on 2026-03-18

200

Participants Needed

13

Research Sites

90 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Chongqing Medical University

Lead Sponsor

A

Anhui Provincial Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 3Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 1 to 3 years
  • BMI for Age Z-score less than -2
  • Height-for-age Z-score less than -2
  • Total daily energy intake less than 75% of recommended nutrient intake
  • Child's guardian willing to participate and sign an informed consent form
Not Eligible

You will not qualify if you...

  • Chronic or severe infectious diseases such as chronic hepatitis, HIV, or tuberculosis
  • Congenital or genetic diseases affecting growth and development (e.g., congenital heart disease, Down's syndrome, infantile anorexia nervosa), malignancies, or current use of drugs like diuretics, appetite stimulants, steroids, or growth hormones
  • Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, or inflammatory bowel disease
  • Acute or chronic respiratory or digestive infections within 2 weeks before enrollment
  • Allergy or contraindication to ingredients in the high-energy nutritional formula
  • Use of high-energy enteral nutrition preparations within the last 3 months

AI-Screening

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Trial Site Locations

Total: 13 locations

1

Anhui Provincial Children's Hospital

Hefei, Anhui, China, 230001

Actively Recruiting

2

Children's Hospital of The Capital Institute of Pediatrics

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

3

The First Hospital of Jilin University

Jilin, Changchun, China

Actively Recruiting

4

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, China, 400014

Actively Recruiting

5

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China, 510200

Actively Recruiting

6

Guiyang Maternity and Child Health Care Hospital

Guiyang, Guizhou, China, 550003

Actively Recruiting

7

Hunan Children's Hospital

Changsha, Hunan, China, 410007

Actively Recruiting

8

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China, 210004

Actively Recruiting

9

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China, 330006

Actively Recruiting

10

Baoji Maternity and Child Healthcare Hospital

Baoji, Shanxi, China, 721000

Actively Recruiting

11

Xianyang Children's Hospital

Xianyang, Shanxi, China, 712000

Actively Recruiting

12

Chengdu Women's and Children's Central Hospital,School of Medicine,University of Electronic Science and Technology of China

Chengdu, Sichuan, China, 610091

Actively Recruiting

13

Kunming Children's Hospital

Kunming, Yunnan, China, 650000

Actively Recruiting

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Research Team

L

Li Chen, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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