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Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers

NCT ID: NCT02950740

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Child Nutrition Disorders

Keywords

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malnutrition

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Center 01 (SA)

Toddlers from Santo André Early Childhood Public School

No interventions assigned to this group

Center 02 (POA)

Toddlers from Porto Alegre Early Childhood Public School

No interventions assigned to this group

Center 03 (MG)

Toddlers from Uberaba Early Childhood Public School

No interventions assigned to this group

Center 04 (RN)

Toddlers from Natal Early Childhood Public School

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculdade de Medicina do ABC

OTHER

Sponsor Role collaborator

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role collaborator

Universidade Federal do Triangulo Mineiro

OTHER

Sponsor Role collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role collaborator

Danone Early Life Nutrition Brazil

INDUSTRY

Sponsor Role lead

Responsible Party

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Karina Vieira de Barros Munhoz

Health Care Nutrition Science Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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DanoneELN-01

Identifier Type: -

Identifier Source: org_study_id