Clinical trial NCT02950740: Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers
Official title: Evaluation of Nutritional Status, Food Intake and Fecal Microbiota of 1-3 Year-old Children From Four Regions of Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Nutrition Disorders
Keywords: malnutrition
Lead sponsor: Danone Early Life Nutrition Brazil
Sponsor class: INDUSTRY
Collaborators: name: Faculdade de Medicina do ABC
name: Universidade Federal do Rio Grande do Norte
name: Universidade Federal do Triangulo Mineiro
name: Federal University of Health Science of Porto Alegre
First posted: 2016-11-01
Enrollment: 228
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 200 children aged between 1-3 years, under full-time regimen in public schools of four cities of Brazil (Santo André, Uberaba, Porto Alegre and Natal). Fifty children of each city will be evaluated.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children aged between 1-3 years
* Enrolled under full-time regimen in public schools
* Without any acute infection at the time of data collection.

Exclusion Criteria:

* Any chronic disease or congenital malformation
* Use of antibiotics in the past 30 days.

Primary outcomes:
measure: Child Nutritional disorders
timeFrame: up to two months
Secondary outcomes:
measure: Levels of blood cells
timeFrame: up to three months
measure: Fatty acids composition
timeFrame: up to three months
measure: Microbiota
timeFrame: up to three months
measure: deficiency of minerals
timeFrame: up to three months
measure: Deficiency of retinol
timeFrame: up to three months
measure: Levels of alkaline phosphatase
timeFrame: up to three months
measure: Levels of ferritin
timeFrame: up to three months
measure: Deficiency of vitamin D
timeFrame: up to three months
measure: Food intake
timeFrame: up to two months
measure: Problems in child growth
timeFrame: up to two months
Other outcomes:
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