the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- BMI for Age Z-score(BAZ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
high caloric oral nutritional supplements group
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.
干预措施: high caloric oral nutritional supplements (Dietary Supplement)
high caloric oral nutritional supplements group
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.
干预措施: nutritional education (Behavioral)
high caloric oral nutritional supplements group
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.
干预措施: dietary guidance (Behavioral)
nutritional education and dietary guidance group
Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutrition education and dietary instruction.
干预措施: nutritional education (Behavioral)
nutritional education and dietary guidance group
Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutrition education and dietary instruction.
干预措施: dietary guidance (Behavioral)
结局指标
主要结局
BMI for Age Z-score(BAZ)
时间窗: 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.
次要结局
- Dietary Diary(at 0, 1, 2, 3, 6 and 12 months of enrollment)
- Urine Routine Test(at 0, 6 and 12 months of enrollment)
- Height for Age Z-score(HAZ)(at 0, 1, 2, 3, 6 and 12 months of enrollment)
- Pediatric Quality of Life Inventory (PedsQL)(at 0, 6, and 12 months of enrollment)
- Infectious Diseases Related Questionnaire(at 0, 1，3, 6, and 12 months of enrollment)
- Renal Function Test(at 0, 6 and 12 months of enrollment)
- BMI for Age Z-score(BAZ)(at 0, 1, 2, 3 and 12 months of enrollment)
- the Chinese version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF)(at 0, 6 and 12 months of enrollment)
- Gut Health Questionnaire(at 0, 1，3, 6, and 12 months of enrollment)
- Blood Routine Test(at 0, 6 and 12 months of enrollment)
- Weight for Age Z-score(WAZ)(at 0, 1, 2, 3, 6 and 12 months of enrollment)
- Gesell Developmental Scale Test(at 0, 6, and 12 months of enrollment)
- Infants - Junior High School Students Social Competence Test (S-M test)(at 0, 6, and 12 months of enrollment)
- Liver Function Test(at 0, 6 and 12 months of enrollment)
研究者
Chen Li
Associate Professor, Director
Children's Hospital of Chongqing Medical University