Clinical Trial: Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Danone Early Life Nutrition Brazil

Current Primary Outcome: Child Nutritional disorders [ Time Frame: up to two months ]

Obesity, overweight


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Levels of blood cells [ Time Frame: up to three months ]
    laboratory parameters: blood count
  • Fatty acids composition [ Time Frame: up to three months ]
    analysis in erythrocytes
  • Microbiota [ Time Frame: up to three months ]
    Diversity of fecal microbiota
  • deficiency of minerals [ Time Frame: up to three months ]
    laboratory parameters: calcium, zinc, selenium
  • Deficiency of retinol [ Time Frame: up to three months ]
    Laboratory parameters: blood retinol
  • Levels of alkaline phosphatase [ Time Frame: up to three months ]
    Laboratory parameters:alkaline phosphatase
  • Levels of ferritin [ Time Frame: up to three months ]
    Laboratory parameters: ferritin
  • Deficiency of vitamin D [ Time Frame: up to three months ]
    Laboratory parameters:level of vitamin D
  • Food intake [ Time Frame: up to two months ]
    Direct food weighing
  • Problems in child growth [ Time Frame: up to two months ]
    stunting


Original Secondary Outcome: Same as current

Information By: Danone Early Life Nutrition Brazil

Dates:
Date Received: March 31, 2016
Date Started: October 2015
Date Completion:
Last Updated: October 28, 2016
Last Verified: October 2016