Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers

Child Nutrition Disorders Clinical Trial

— Nutrilife  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950740
• Other study ID #: DanoneELN-01
• Status: Completed
• Phase: N/A
• First received: March 31, 2016
• Last updated: October 28, 2016
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Danone Early Life Nutrition Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorders

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Danone Early Life Nutrition Brazil	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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Nutritional disorders	Obesity, overweight	up to two months	Yes
Secondary	Levels of blood cells	laboratory parameters: blood count	up to three months	Yes
Secondary	Fatty acids composition	analysis in erythrocytes	up to three months	Yes
Secondary	Microbiota	Diversity of fecal microbiota	up to three months	Yes
Secondary	deficiency of minerals	laboratory parameters: calcium, zinc, selenium	up to three months	Yes
Secondary	Deficiency of retinol	Laboratory parameters: blood retinol	up to three months	Yes
Secondary	Levels of alkaline phosphatase	Laboratory parameters:alkaline phosphatase	up to three months	Yes
Secondary	Levels of ferritin	Laboratory parameters: ferritin	up to three months	Yes
Secondary	Deficiency of vitamin D	Laboratory parameters:level of vitamin D	up to three months	Yes
Secondary	Food intake	Direct food weighing	up to two months	Yes
Secondary	Problems in child growth	stunting	up to two months	Yes