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Completed

NCT Number: NCT02950740

Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers

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.

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Key information

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Child Nutritional disorders

    Time frame: up to two months

    Obesity, overweight

Secondary outcomes

  1. Levels of blood cells

    Time frame: up to three months

    laboratory parameters: blood count

  2. Fatty acids composition

    Time frame: up to three months

    analysis in erythrocytes

  3. Microbiota

    Time frame: up to three months

    Diversity of fecal microbiota

  4. deficiency of minerals

    Time frame: up to three months

    laboratory parameters: calcium, zinc, selenium

  5. Deficiency of retinol

    Time frame: up to three months

    Laboratory parameters: blood retinol

  6. Levels of alkaline phosphatase

    Time frame: up to three months

    Laboratory parameters:alkaline phosphatase

  7. Levels of ferritin

    Time frame: up to three months

    Laboratory parameters: ferritin

  8. Deficiency of vitamin D

    Time frame: up to three months

    Laboratory parameters:level of vitamin D

  9. Food intake

    Time frame: up to two months

    Direct food weighing

  10. Problems in child growth

    Time frame: up to two months

    stunting

Sponsors and collaborators

Lead sponsor

Danone Early Life Nutrition Brazil

Industry

Collaborators

  • Faculdade de Medicina do ABC
  • Federal University of Health Science of Porto Alegre
  • Universidade Federal do Rio Grande do Norte
  • Universidade Federal do Triangulo Mineiro

Registry information

Official study title

Evaluation of Nutritional Status, Food Intake and Fecal Microbiota of 1-3 Year-old Children From Four Regions of Brazil

Acronym: Nutrilife

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 1, 2016
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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