Malnutrition, ChildEHCONSGDMCNCT05911893
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
A study testing high caloric oral nutritional supplements, nutritional education and dietary guidance in people with Malnutrition, Child and Malnourishment, run by Children's Hospital of Chongqing Medical University at 13 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Malnutrition, Child, Malnourishment, Nutritional Deficiency
- What is being tested?
- high caloric oral nutritional supplements, nutritional education and dietary guidance
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesChina
- Study dates
- 17 Jun 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Baoji Maternity and Child Healthcare Hospital
Baoji, Shanxi, 721000
Xueqin Li, master's degree, 15229681332 ext. +86, 85581703@qq.com
- Recruiting
Children's Hospital of The Capital Institute of Pediatrics
Beijing, Beijing Municipality, 100020
Lin Wang, MD, 13501362346 ext. +86, caroldoctor@126.com
- Recruiting
Hunan Children's Hospital
Changsha, Hunan, 410007
Yan Zhong, bachelor's degree, 13873170189 ext. +86, zhongyan@163.com
- Recruiting
Chengdu Women's and Children's Central Hospital，School of Medicine，University of Electronic Science and Technology of China
Chengdu, Sichuan, 610091
Lan Zhang, master's degree, 13982156971 ext. +86, 893279990@qq.com
- Recruiting
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, 400014
Li Chen, MD, (+86)136 7762 0103 ext. +86, chenli2012@126.com
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510200
Yan Hu, master's degree, 13560366657 ext. +86, yayayan1979@163.com
- Recruiting
Guiyang Maternity and Child Health Care Hospital
Guiyang, Guizhou, 550003
Yan Luo, MD, 18585011079 ext. +86, 718410342@qq.com
- Recruiting
Anhui Provincial Children's Hospital
Hefei, Anhui, 230001
Ya Wang, master's degree, 13855150595 ext. +86, 22891588@qq.com
- Recruiting
The First Hospital of Jilin University
Jilin City, Changchun
Feiyong Jia, 13943003914 ext. +86
- Recruiting
Kunming Children's Hospital
Kunming, Yunnan, 650000
Yu Ling, bachelor's degree, 13888594860 ext. +86, lingyu@etyy.cn
- Recruiting
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
Ping Xu, bachelor's degree, 13879112716 ext. +86, 278938835@qq.com
- Recruiting
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
Xia Chi, MD, 13813875862 ext. +86, 264601855@qq.com
- Recruiting
Xianyang Children's Hospital
Xianyang, Shanxi, 712000
Hongxia Yan, bachelor's degree, 15909263117 ext. +86, 1142179306@qq.com
About this study
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.
Read the 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.
- Being tested
- high caloric oral nutritional supplements, nutritional education, dietary guidance
- Keywords
- Oral Nutritional Supplements, Physique Growth, Neuropsychological Development
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high caloric oral nutritional supplementsDietary supplement
Also called high-energy total nutrition formula
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 educationBehavioural
After enrollment,health education information is pushed approximately every 4 weeks through the WeChat platform or/and short text messages to parents.
dietary guidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| high caloric oral nutritional supplements group | Experimental | Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutritional education,dietary instruction and daily high caloric oral nutritional supplements for 12 months. Receives: Dietary Supplement: high caloric oral nutritional supplements; Behavioral: nutritional education; Behavioral: dietary guidance |
| nutritional education and dietary guidance group | Active comparator | Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutrition education and dietary instruction. Receives: Behavioral: nutritional education; Behavioral: dietary guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI for Age Z-score(BAZ)
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
Measured: at 6 months of enrollment
Secondary outcomes (14)
Dietary Diary
Participants provide a dietary diary over an average two-day period through a WeChat app each visit. The app prompts participants to record and estimate details of all meals and snacks they consumed, especially formula used in the study.
Measured: at 0, 1, 2, 3, 6 and 12 months of enrollment
BMI for Age Z-score(BAZ)
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
Measured: at 0, 1, 2, 3 and 12 months of enrollment
Weight for Age Z-score(WAZ)
Trained research assistants or health care practitioners obtain weight in kilograms using a standardized approach. Weight is measured using a precision digital scale or mechanical scale(mean of 3 consecutive measurements). Then, the WAZ is calculated using WHO2011v3.2.2 software.
Measured: at 0, 1, 2, 3, 6 and 12 months of enrollment
Height for Age Z-score(HAZ)
Trained research assistants or health care practitioners obtain height in centimeters using a standardized approach. Height is measured with a calibrated stadiometer(mean of 3 consecutive measurements). Then, the HAZ is calculated using WHO2011v3.2.2 software.
Measured: at 0, 1, 2, 3, 6 and 12 months of enrollment
Gesell Developmental Scale Test
Mainly assesses participants in 5 areas:adaptive behavior, gross motor, fine motor, language behavior,personal-social behavior, the evaluation finally calculates the developmental quotient (DQ) of each area. Diagnostic criteria: DQ is more than or equal to 86 is normal, DQ is marginal between 76 and 85, DQ is mild mental retardation between 55 and 75, DQ is moderate mental retardation between 40 and 54, DQ is severe mental retardation between 25 and 39, and DQ is less than or equal to 25 is extremely severe mental retardation.
Measured: at 0, 6, and 12 months of enrollment
Infants - Junior High School Students Social Competence Test (S-M test)
The scale, derived from the revised version of the Japanese Social Competence test (S-M test) and revised by a Chinese researcher, is applicable to children from 6 months of age to 14 years of age and includes 132 items in 6 sections with 7 starting ages, which are filled in item by item by parents or daily caregivers according to the appropriate age, with ≥10 being normal.
Measured: at 0, 6, and 12 months of enrollment
Pediatric Quality of Life Inventory (PedsQL)
The quality of life of the participants is assessed using the Pediatric Quality of Life Inventory.The Infant Scale or Generic Core Scales is completed according to age.Scores are transformed on a scale from 0 to 100,with higher scores indicating better quality of life.
Measured: at 0, 6, and 12 months of enrollment
the Chinese version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
The quality of life of parents is assessed using the WHOQOL-BREF.The WHOQOL-BREF, comprises 26 items, two general items and 24 others, across the following four domains: physical (7 items), psychological (6 items), social (3 items), and environmental (8 items).Calculate the average score of all items in each domain, converted into a score of 4 to 20 or 0 to100 by two algorithms,with higher scores indicating better quality of life.
Measured: at 0, 6 and 12 months of enrollment
Gut Health Questionnaire
A questionnaire is used to understand gut health, including entries on the Bristol Stool Scale (to assess stool status), the average number of bowel movements per day, and the frequency of bloating and abdominal pain.
Measured: at 0, 1，3, 6, and 12 months of enrollment
Infectious Diseases Related Questionnaire
A infectious disease-related questionnaire is used to understand immune function, including the number and duration of upper respiratory tract infections, infectious diarrhea.
Measured: at 0, 1，3, 6, and 12 months of enrollment
Blood Routine Test
Blood routine test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:white blood cell count,red blood cell count,hemoglobin,mean corpuscular hemoglobin concentration,platelet,standard deviation in red cell distribution width,coefficient variation of red blood cell volume distribution width,platelet distribution width,mean platelet volume,platelet larger cell ratio,thrombocytocrit,neutrophil ratio,lymphocyte ratio,monocyte ratio,eosinophil ratio,basophil ratio,neutrophil count,lymphocyte count,monocyte count,eosinophil count,basophil count.
Measured: at 0, 6 and 12 months of enrollment
Liver Function Test
Liver function test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:total protein,albumin,globulin,alanineamino transferase,aspartate amino transferase,bilirubin,direct bilirubin,total bile acid,alkaline phosphatase,amma-glutamyl transpeptidase.
Measured: at 0, 6 and 12 months of enrollment
Renal Function Test
Renal function test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:creatinine,blood urea nitrogen.
Measured: at 0, 6 and 12 months of enrollment
Urine Routine Test
Urine routine test is completed at 0, 6 and 12 months of enrollment for safety analysis.Includes the following parameters:urinary bilirubin,urinary ketone bodies,blood,urinary white blood cells,urinary red blood cells,urinary sugar,urinary protein,urinary cast.
Measured: at 0, 6 and 12 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start17 Jun 2024
- Primary completion10 Mar 2026
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Provincial Children's Hospital, Baoji Maternity and Child Healthcare Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital, Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Nanjing Maternity and Child Health Care Hospital, Children's Hospital of The Capital Institute of Pediatrics, Xianyang Children's Hospital, Nestle Health Science, The First Hospital of Jilin University
- Responsible party
- Principal investigator, Chen Li, Children's Hospital of Chongqing Medical University
- Investigators
- Li Chen, doctor, Study director, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911893
- Sponsor's protocol ID
- EHCONSGDMC
- Acronym
- EHCONSGDMC
- Status last verified
- Nov 2025
- First submitted
- 16 May 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Publications
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.
PubMed 30413417
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
- ClinicalTrials.gov ID
- NCT05911893
- Acronym / sponsor ID
- EHCONSGDMC / EHCONSGDMC
- Keywords
- Oral Nutritional Supplements, Physique Growth, Neuropsychological Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Anhui Provincial Children's Hospital, Baoji Maternity and Child Healthcare Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital, Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Nanjing Maternity and Child Health Care Hospital, Children's Hospital of The Capital Institute of Pediatrics, Xianyang Children's Hospital, Nestle Health Science, The First Hospital of Jilin University
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| high caloric oral nutritional supplements group | Experimental | Dietary Supplement: high caloric oral nutritional supplements, Behavioral: nutritional education, Behavioral: dietary guidanceParticipants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutritional education,dietary instruction and daily high caloric oral nutritional supplements for 12 months. |
| nutritional education and dietary guidance group | Active comparator | Behavioral: nutritional education, Behavioral: dietary guidanceParticipants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutrition education and dietary instruction. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high caloric oral nutritional supplementsAlso: high-energy total nutrition formulaHigh 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. | Dietary supplement | high caloric oral nutritional supplements group |
| nutritional educationAfter enrollment,health education information is pushed approximately every 4 weeks through the WeChat platform or/and short text messages to parents. | Behavioural | high caloric oral nutritional supplements group, nutritional education and dietary guidance group |
| dietary guidanceAt 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. | Behavioural | high caloric oral nutritional supplements group, nutritional education and dietary guidance group |
Primary outcome
BMI for Age Z-score(BAZ)
Time frame: at 6 months of enrollment
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
14 secondary outcomes
Dietary Diary
Time frame: at 0, 1, 2, 3, 6 and 12 months of enrollment
BMI for Age Z-score(BAZ)
Time frame: at 0, 1, 2, 3 and 12 months of enrollment
Weight for Age Z-score(WAZ)
Time frame: at 0, 1, 2, 3, 6 and 12 months of enrollment
Height for Age Z-score(HAZ)
Time frame: at 0, 1, 2, 3, 6 and 12 months of enrollment
Gesell Developmental Scale Test
Time frame: at 0, 6, and 12 months of enrollment
Infants - Junior High School Students Social Competence Test (S-M test)
Time frame: at 0, 6, and 12 months of enrollment
Pediatric Quality of Life Inventory (PedsQL)
Time frame: at 0, 6, and 12 months of enrollment
the Chinese version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: at 0, 6 and 12 months of enrollment
Gut Health Questionnaire
Time frame: at 0, 1，3, 6, and 12 months of enrollment
Infectious Diseases Related Questionnaire
Time frame: at 0, 1，3, 6, and 12 months of enrollment
Blood Routine Test
Time frame: at 0, 6 and 12 months of enrollment
Liver Function Test
Time frame: at 0, 6 and 12 months of enrollment
Renal Function Test
Time frame: at 0, 6 and 12 months of enrollment
Urine Routine Test
Time frame: at 0, 6 and 12 months of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 30413417Hemming 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.
- Individual participant dataSharing planned: No. Data is confidential during the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Chen, doctor study director
Children's Hospital of Chongqing Medical University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high caloric oral nutritional supplements, nutritional education and dietary guidance in people with Malnutrition, Child and Malnourishment, run by Children's Hospital of Chongqing Medical University at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Chen, doctor (136 7762 0103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI for Age Z-score(BAZ) (time frame: at 6 months of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.