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

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.

Conditions

• Malnutrition, Child
• Malnourishment
• Nutritional Deficiency
• Undernutrition

Interventions

DIETARY_SUPPLEMENT

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.

BEHAVIORAL

nutritional education

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

BEHAVIORAL

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.

Sponsors & Collaborators

• Anhui Provincial Children's Hospital

  collaborator OTHER

• Baoji Maternity and Child Healthcare Hospital

  collaborator UNKNOWN

• Chengdu Women's and Children's Central Hospital

  collaborator OTHER

• Guiyang Maternity and Child Health Care Hospital

  collaborator OTHER

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Jiangxi Maternal and Child Health Hospital

  collaborator OTHER

• Kunming Children's Hospital

  collaborator OTHER

• Nanjing Maternity and Child Health Care Hospital

  collaborator OTHER

• Children's Hospital of The Capital Institute of Pediatrics

  collaborator OTHER

• Xianyang Children's Hospital

  collaborator OTHER

• Nestle Health Science

  collaborator INDUSTRY

• The First Hospital of Jilin University

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  lead OTHER

Principal Investigators

• Li Chen, doctor · Children's Hospital of Chongqing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-17

Primary Completion

2026-03-10

Completion

2026-03-10

Countries

• China

Study Locations