Clinical trial NCT05911893: the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Official title: the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Malnourishment
Nutritional Deficiency
Undernutrition
Keywords: Oral Nutritional Supplements
Physique Growth
Neuropsychological Development
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Anhui Provincial Children's Hospital
name: Baoji Maternity and Child Healthcare Hospital
name: Chengdu Women's and Children's Central Hospital
name: Guiyang Maternity and Child Health Care Hospital
name: Guangzhou Women and Children's Medical Center
name: Hunan Children's Hospital
name: Jiangxi Maternal and Child Health Hospital
name: Kunming Children's Hospital
name: Nanjing Maternity and Child Health Care Hospital
name: Children's Hospital of The Capital Institute of Pediatrics
name: Xianyang Children's Hospital
name: Nestle Health Science
First posted: 2023-06-22
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants aged 1 to 3 years who are malnourished (underweight and wasting) are randomly divided into an experimental group and a control group. The experimental group is given nutritional education and high-energy total nutrition formula, while the control group is given nutritional education and dietary guidance. At the 1-month, 2-month, 3-month, and 6-month follow-ups of enrollment, children in the control group are transferred to the trial group if the assessment revealed that they are unable to achieve ≥75% of their predicted nutritional requirements through dietary modification or their rate of weight gain do not improve, according to the study design principles of the stepped wedge cluster trial.
Primary purpose: TREATMENT

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 800 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.

Eligibility 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

Primary outcomes:
measure: BMI for Age Z-score(BAZ)
timeFrame: at 6 months of enrollment
Secondary outcomes:
measure: Dietary Diary
timeFrame: at 0, 1, 2, 3, 6 and 12 months of enrollment
measure: BMI for Age Z-score(BAZ)
timeFrame: at 0, 1, 2, 3 and 12 months of enrollment
measure: Weight for Age Z-score(WAZ)
timeFrame: at 0, 1, 2, 3, 6 and 12 months of enrollment
measure: Height for Age Z-score(HAZ)
timeFrame: at 0, 1, 2, 3, 6 and 12 months of enrollment
measure: Gesell Developmental Scale Test
timeFrame: at 0, 6, and 12 months of enrollment
measure: Infants - Junior High School Students Social Competence Test (S-M test)
timeFrame: at 0, 6, and 12 months of enrollment
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: at 0, 6, and 12 months of enrollment
measure: the Chinese version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: at 0, 6 and 12 months of enrollment
measure: Gut Health Questionnaire
timeFrame: at 0, 1，3, 6, and 12 months of enrollment
measure: Infectious Diseases Related Questionnaire
timeFrame: at 0, 1，3, 6, and 12 months of enrollment
measure: Blood Routine Test
timeFrame: at 0, 6 and 12 months of enrollment
measure: Liver Function Test
timeFrame: at 0, 6 and 12 months of enrollment
measure: Renal Function Test
timeFrame: at 0, 6 and 12 months of enrollment
measure: Urine Routine Test
timeFrame: at 0, 6 and 12 months of enrollment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Beijing
country: China
facility: Children's Hospital of The Capital Institute of Pediatrics
state: Beijing
city: Chongqing
country: China
facility: Growth, Development and Mental health of Children and Adolescence Center
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guiyang
country: China
facility: Guiyang Maternity and Child Health Care Hospital
state: Guizhou
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Baoji
country: China
facility: Baoji Maternity and Child Healthcare Hospital
state: Shanxi
city: Xianyang
country: China
facility: Xianyang Children's Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital，School of Medicine，University of Electronic Science and Technology of China
state: Sichuan
city: Kunming
country: China
facility: Kunming Children's Hospital
state: Yunnan
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Li Chen, doctor
role: STUDY_DIRECTOR
References:
citation: Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018 Nov 9;363:k1614. doi: 10.1136/bmj.k1614.