Child Nutrition DisordersNutrilifeNCT02950740
Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers
An observational study of Child Nutrition Disorders, run by Danone Early Life Nutrition Brazil.
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. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Nutrition Disorders
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children aged between 1-3 years
- Enrolled under full-time regimen in public schools
- Without any acute infection at the time of data collection.
Who cannot join
- Any chronic disease or congenital malformation
- Use of antibiotics in the past 30 days.
About this study
Official title: Evaluation of Nutritional Status, Food Intake and Fecal Microbiota of 1-3 Year-old Children From Four Regions of Brazil
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.
Read the 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.
- Conditions
- Child Nutrition Disorders
- Keywords
- malnutrition
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Center 01 (SA) | Toddlers from Santo André Early Childhood Public School | |
| Center 02 (POA) | Toddlers from Porto Alegre Early Childhood Public School | |
| Center 03 (MG) | Toddlers from Uberaba Early Childhood Public School | |
| Center 04 (RN) | Toddlers from Natal Early Childhood Public School |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Nutritional disorders
Obesity, overweight
Measured: up to two months
Secondary outcomes (10)
Levels of blood cells
laboratory parameters: blood count
Measured: up to three months
Fatty acids composition
analysis in erythrocytes
Measured: up to three months
Microbiota
Diversity of fecal microbiota
Measured: up to three months
deficiency of minerals
laboratory parameters: calcium, zinc, selenium
Measured: up to three months
Deficiency of retinol
Laboratory parameters: blood retinol
Measured: up to three months
Levels of alkaline phosphatase
Laboratory parameters:alkaline phosphatase
Measured: up to three months
Levels of ferritin
Laboratory parameters: ferritin
Measured: up to three months
Deficiency of vitamin D
Laboratory parameters:level of vitamin D
Measured: up to three months
Food intake
Direct food weighing
Measured: up to two months
Problems in child growth
stunting
Measured: up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Early Life Nutrition Brazil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Faculdade de Medicina do ABC, Universidade Federal do Rio Grande do Norte, Universidade Federal do Triangulo Mineiro, Federal University of Health Science of Porto Alegre
- Responsible party
- Principal investigator, Karina Vieira de Barros Munhoz, Danone Early Life Nutrition Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950740
- Sponsor's protocol ID
- DanoneELN-01
- Acronym
- Nutrilife
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Status, Food Intake and Fecal Microbiota of 1-3 Year-old Children From Four Regions of Brazil
- ClinicalTrials.gov ID
- NCT02950740
- Acronym / sponsor ID
- Nutrilife / DanoneELN-01
- Conditions
- Child Nutrition Disorders
- Keywords
- malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Danone Early Life Nutrition BrazilIndustry (pharma, biotech, devices)
- Collaborators
- Faculdade de Medicina do ABC, Universidade Federal do Rio Grande do Norte, Universidade Federal do Triangulo Mineiro, Federal University of Health Science of Porto Alegre
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Center 01 (SA) | – | –Toddlers from Santo André Early Childhood Public School |
| Center 02 (POA) | – | –Toddlers from Porto Alegre Early Childhood Public School |
| Center 03 (MG) | – | –Toddlers from Uberaba Early Childhood Public School |
| Center 04 (RN) | – | –Toddlers from Natal Early Childhood Public School |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children aged between 1-3 years
- Enrolled under full-time regimen in public schools
- Without any acute infection at the time of data collection.
Key exclusion criteria (2 listed)
- Any chronic disease or congenital malformation
- Use of antibiotics in the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child Nutritional disorders
Time frame: up to two months
Obesity, overweight
10 secondary outcomes
Levels of blood cells
Time frame: up to three months
Fatty acids composition
Time frame: up to three months
Microbiota
Time frame: up to three months
deficiency of minerals
Time frame: up to three months
Deficiency of retinol
Time frame: up to three months
Levels of alkaline phosphatase
Time frame: up to three months
Levels of ferritin
Time frame: up to three months
Deficiency of vitamin D
Time frame: up to three months
Food intake
Time frame: up to two months
Problems in child growth
Time frame: up to two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Nutrition Disorders, run by Danone Early Life Nutrition Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Nutritional disorders (time frame: up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.