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the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Sponsor: Children's Hospital of Chongqing Medical University
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.
Key Details
Gender
All
Age Range
1 Year - 3 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-06-17
Completion Date
2026-03-10
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
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.
Locations (13)
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Children's Hospital of The Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
The First Hospital of Jilin University
Jilin, Changchun, China
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Guiyang Maternity and Child Health Care Hospital
Guiyang, Guizhou, China
Hunan Children's Hospital
Changsha, Hunan, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Baoji Maternity and Child Healthcare Hospital
Baoji, Shanxi, China
Xianyang Children's Hospital
Xianyang, Shanxi, China
Chengdu Women's and Children's Central Hospital，School of Medicine，University of Electronic Science and Technology of China
Chengdu, Sichuan, China
Kunming Children's Hospital
Kunming, Yunnan, China