Evaluation of Nutritional Status, Food Intake and Fecal Microbiota of 1-3 Year-old Children From Four Regions of Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 主要终点
- Child Nutritional disorders
研究概览
简要总结
Food intake pattern and lifestyle are associated with the nutritional status and intestinal microbiota composition, and such factors are important for the proper growth and development during early childhood, as well as for the health throughout life. This cross-sectional and multicenter study will include a total of 200 children aged between 1-3 years, enrolled in early childhood public schools from different regions of Brazil (Santo André, Uberaba, Porto Alegre and Natal). Data on birth and gestational history will be collected in a form. Nutritional status will be assessed by determining the weight and height, with subsequent calculations and classification of nutritional indices. A single blood sample will be collected to investigate the blood levels of vitamins A and D, iron, calcium, alkaline phosphatase and zinc, and feces will be collected for intestinal microbiota analysis. Food intake will be assessed by direct weighing of food in 2 non-consecutive days. Considering the importance of a well-balanced diet and its effects on the child's growth, development and intestinal colonization, this study purpose is to investigate potential associations among food intake, nutritional status and intestinal microbiota of early childhood infants from four regions of Brazil.
详细描述
It is a cross-sectional and multicenter study to examine two hundred children aged between 1-3 years, duly enrolled under full-time regimen in public schools of the cities of Santo André (SP), Uberaba (MG), Porto Alegre (RS) and Natal (RN). The Principal Site of study will be Fundação de Medicina do ABC, located in the city of Santo André, while Universidade Federal do Triângulo Mineiro, Universidade Federal of Ciências da Saúde de Porto Alegre and Universidade Federal do Rio Grande do Norte will be the other Sites. For such purpose, fifty children from each Early Childhood Public School will be screened according to the inclusion criteria and invited to participate in the study. Each State may include more than one Institution, if required to reach the total number of children established previously.
After the authorization and signature of the Informed Consent Form - ICF - (Attachment I) are given by the mother or legal responsible, such person must go to the Institution on the scheduled date for the collection of a blood sample and to deliver of a stool sample, collected as per prior orientation. The interviewer shall complete a questionnaire to obtain information on the birth and gestational history and current information on the child. A single blood sample will be collected for analysis of vitamins A and D, calcium, iron, ferritin, hemoglobin, zinc, selenium, alkaline phosphatase and lipids (cholesterol - total and fractions - and triglycerides), and a stool sample will be collected for analysis of parasites and microbiota in the feces.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 3 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 1-3 years
- •Enrolled under full-time regimen in public schools
- •Without any acute infection at the time of data collection.
排除标准
- •Any chronic disease or congenital malformation
- •Use of antibiotics in the past 30 days.
结局指标
主要结局
Child Nutritional disorders
时间窗: up to two months
Obesity, overweight
次要结局
- Levels of blood cells(up to three months)
- deficiency of minerals(up to three months)
- Deficiency of retinol(up to three months)
- Levels of alkaline phosphatase(up to three months)
- Levels of ferritin(up to three months)
- Fatty acids composition(up to three months)
- Microbiota(up to three months)
- Deficiency of vitamin D(up to three months)
- Food intake(up to two months)
- Problems in child growth(up to two months)
研究者
Karina Vieira de Barros Munhoz
Health Care Nutrition Science Manager
Danone Early Life Nutrition Brazil
