Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05911893
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2023-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Sponsor:
Children's Hospital of Chongqing Medical University
Organization:
Study Overview
Official Title:
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EHCONSGDMC
Brief 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.
Detailed Description:
Background:Growth and development is an important indicator of children's health and nutritional status, and nutrition is the most important material basis for growth and development. The prevention and treatment of malnutrition in children can be achieved by choosing whole nutritional formulas for special medical purposes as oral nutritional supplements (ONS), which has been confirmed by some overseas clinical studies to promote the growth benefit of malnourished children, but no multicenter clinical study has been conducted in China on the effect of ONS on the improvement of growth and development of malnourished Chinese children.
Objective and significance: To investigate the effects of high caloric ONS on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in children, as well as to evaluate the safety of applying high caloric ONS, and to provide data to support the development of clinical intervention strategies for malnourished Chinese children.
Research design:A multicenter, randomized, controlled clinical trial design method is used to randomize children who meet the inclusion criteria into the experimental and control groups using a competitive entry method. The test group is given nutritional education and high caloric ONS (which can supplement 30% of the energy requirement), while the control group is given nutritional education and dietary instruction.Participants are followed up at 0, 1,2, 3, 6, and 12 months of enrollment. The investigators will collect dietary diaries, physical indicators, developmental quotient scores, quality of life measures, gut health, infectious disease-related questionnaires and safety indicators (blood biochemical indicators, urine routine) from children in both groups to comprehensively assess the effect of high caloric ONS intervention on physical growth, neuropsychological development levels and related aspects (gut health, immune function, quality of life, etc.) of malnourished children, as well as to conduct safety analyses.
Sample size:According to similar studies to date, a total of 200 people are recommended for this study.
Statistical analysis: Statistical analysis is performed using SAS 9.4. For continuous variables (height, weight, BMI-Z score, DQ score, etc.), statistical descriptions are performed using mean and standard deviation (conforming to normal distribution) or median and interquartile range (IQR); for categorical variables, statistical descriptions are performed using frequency and percentage; for the main efficacy indicators, mixed-effects models are used for efficacy evaluation indicators according to the principle of adjusted intentionality analysis (mITT). For the safety evaluation, the number, frequency and incidence of adverse events and reactions are calculated, and the positive abnormal changes of laboratory biochemical indexes such as blood routine, urine routine, liver and kidney function are counted. p value \< 0.05 is considered statistically significant.
Ethical matters and data protection: The guardians of the children participating in the study will sign an informed consent form. This study is approved by the local ethics committee. Patients' names will be abbreviated and study data will be assigned a code which will then be provided to the investigator. Parental authorization for patient health information will remain in effect until the study is completed. After that, private information will be removed from the study records by the researcher.
Objective and significance: To investigate the effects of high caloric ONS on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in children, as well as to evaluate the safety of applying high caloric ONS, and to provide data to support the development of clinical intervention strategies for malnourished Chinese children.
Research design:A multicenter, randomized, controlled clinical trial design method is used to randomize children who meet the inclusion criteria into the experimental and control groups using a competitive entry method. The test group is given nutritional education and high caloric ONS (which can supplement 30% of the energy requirement), while the control group is given nutritional education and dietary instruction.Participants are followed up at 0, 1,2, 3, 6, and 12 months of enrollment. The investigators will collect dietary diaries, physical indicators, developmental quotient scores, quality of life measures, gut health, infectious disease-related questionnaires and safety indicators (blood biochemical indicators, urine routine) from children in both groups to comprehensively assess the effect of high caloric ONS intervention on physical growth, neuropsychological development levels and related aspects (gut health, immune function, quality of life, etc.) of malnourished children, as well as to conduct safety analyses.
Sample size:According to similar studies to date, a total of 200 people are recommended for this study.
Statistical analysis: Statistical analysis is performed using SAS 9.4. For continuous variables (height, weight, BMI-Z score, DQ score, etc.), statistical descriptions are performed using mean and standard deviation (conforming to normal distribution) or median and interquartile range (IQR); for categorical variables, statistical descriptions are performed using frequency and percentage; for the main efficacy indicators, mixed-effects models are used for efficacy evaluation indicators according to the principle of adjusted intentionality analysis (mITT). For the safety evaluation, the number, frequency and incidence of adverse events and reactions are calculated, and the positive abnormal changes of laboratory biochemical indexes such as blood routine, urine routine, liver and kidney function are counted. p value \< 0.05 is considered statistically significant.
Ethical matters and data protection: The guardians of the children participating in the study will sign an informed consent form. This study is approved by the local ethics committee. Patients' names will be abbreviated and study data will be assigned a code which will then be provided to the investigator. Parental authorization for patient health information will remain in effect until the study is completed. After that, private information will be removed from the study records by the researcher.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: