Undernutrition Clinical Trial
— EHCONSGDMCOfficial title:
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
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.
Status | Not yet recruiting |
Enrollment | 800 |
Est. completion date | June 30, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 3 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Baoji Maternity and Child Healthcare Hospital | Baoji | Shanxi |
China | Children's Hospital of The Capital Institute of Pediatrics | Beijing | Beijing |
China | Hunan Children's Hospital | Changsha | Hunan |
China | Chengdu Women's and Children's Central Hospital,School of Medicine,University of Electronic Science and Technology of China | Chengdu | Sichuan |
China | Growth, Development and Mental health of Children and Adolescence Center | Chongqing | Chongqing |
China | Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong |
China | Guiyang Maternity and Child Health Care Hospital | Guiyang | Guizhou |
China | Anhui Provincial Children's Hospital | Hefei | Anhui |
China | Kunming Children's Hospital | Kunming | Yunnan |
China | Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi |
China | Nanjing Maternity and Child Health Care Hospital | Nanjing | Jiangsu |
China | Xianyang Children's Hospital | Xianyang | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Chongqing Medical University | Anhui Provincial Children's Hospital, Baoji Maternity and Child Healthcare Hospital, Chengdu Women's and Children's Central Hospital, Children's Hospital of The Capital Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guiyang Maternity and Child Health Care Hospital, Hunan Children's Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Nanjing Maternity and Child Health Care Hospital, Nestle Health Science, Xianyang Children's Hospital |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | at 6 months of enrollment | |
Secondary | 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. | at 0, 1, 2, 3, 6 and 12 months of enrollment | |
Secondary | 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. | at 0, 1, 2, 3 and 12 months of enrollment | |
Secondary | 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. | at 0, 1, 2, 3, 6 and 12 months of enrollment | |
Secondary | 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. | at 0, 1, 2, 3, 6 and 12 months of enrollment | |
Secondary | 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. | at 0, 6, and 12 months of enrollment | |
Secondary | 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. | at 0, 6, and 12 months of enrollment | |
Secondary | 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. | at 0, 6, and 12 months of enrollment | |
Secondary | 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. | at 0, 6 and 12 months of enrollment | |
Secondary | 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. | at 0, 1,3, 6, and 12 months of enrollment | |
Secondary | 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. | at 0, 1,3, 6, and 12 months of enrollment | |
Secondary | 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. | at 0, 6 and 12 months of enrollment | |
Secondary | 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. | at 0, 6 and 12 months of enrollment | |
Secondary | 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. | at 0, 6 and 12 months of enrollment | |
Secondary | 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. | at 0, 6 and 12 months of enrollment |
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