NutritionBoSCCoNCT03297970
Bogota School Children Cohort
An observational study of Nutrition and Child Health, run by University of Michigan at 2 sites in Colombia.
Trial summary
This observational study investigates the associations of nutritional indicators, biomarkers, sociodemographic conditions, and infections with child health, as well as physical, behavioral, and cognitive development. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Nutrition, Child Health, Child Growth
- How many people
- 3,202 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Feb 2006to 11 Aug 2015
- 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 5 to 12 years
- All sexes
- Child
Study population: Children were selected from primary public schools in Bogota, Colombia.
Who may be able to join
- Primary public school enrollment in February 2006
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
FINUSAD - Foundation for Research in Nutrition and Health
Bogotá
University of La Sabana
Chía
About this study
This observational study investigates the associations of nutritional indicators, biomarkers, sociodemographic conditions, and infections with child health, as well as physical, behavioral, and cognitive development. Investigators recruited a random sample of 3202 children from primary public schools in Bogota, Colombia in February 2006 and followed them for a median of 6.5 years. Investigators hypothesized that poor nutritional status at the time of recruitment in middle childhood would be related to adverse health outcomes through adolescence.
- Conditions
- Nutrition, Child Health, Child Growth, Neurocognitive Development, Sexual Maturation, Infectious Morbidity
- Medical subject headings
- Mental Disorders
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 |
|---|---|---|
| Bogota School Children Cohort | Children are classified according to exposure levels of: Micronutrient biomarker indicators: * Ferritin * Hemoglobin * Mean corpuscular volume * Zinc * Vitamin A * Vitamin B12 * Folate * Vitamin D Serum fatty acids Inflammatory biomarkers: * C-reactive protein Diet Socioeconomic status indicators Anthropometric indicators Incidence of infectious morbidity symptoms DNA biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Externalizing behavior problems
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The YSR is a self-administered questionnaire consisting of 112 statements addressing behaviors or feelings that adolescents rate as false, sometimes true, or very/often true. From responses to these questions, an Assessment Data Manager (ADM) software calculates continuous scores for aggressive behavior and rule breaking behavior. The sum of the aggressive and rule breaking behavior subscale scores constitute the total externalizing problems score.
Measured: Assessed at one point in time when the children were 11-18 years old.
Internalizing behavior problems
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The sum of the anxious/depressed, withdrawn/depressed, and somatic complaint subscale scores constitute the total internalizing problems score.
Measured: Assessed at one point in time when the children were 11-18 years old.
Secondary outcomes (1)
Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire.
Measured: Assessed at one point in time when the children were 11-18 years old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Feb 2006
- Primary completion11 Aug 2015
- Study completion11 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de la Sabana, Foundation for Research in Nutrition and Health (FINUSAD)
- Responsible party
- Principal investigator, Eduardo Villamor, University of Michigan
- Investigators
- Eduardo Villamor, MD MPH DrPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297970
- Sponsor's protocol ID
- HUM00043252
- Acronym
- BoSCCo
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robinson SL, Marin C, Oliveros H, Mora-Plazas M, Richards BJ, Lozoff B, Villamor E. Iron Deficiency, Anemia, and Low Vitamin B-12 Serostatus in Middle Childhood Are Associated with Behavior Problems in Adolescent Boys: Results from the Bogota School Children Cohort. J Nutr. 2018 May 1;148(5):760-770. doi: 10.1093/jn/nxy029.
PubMed 29897579
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bogota School Children Cohort
- ClinicalTrials.gov ID
- NCT03297970
- Acronym / sponsor ID
- BoSCCo / HUM00043252
- Conditions
- Nutrition, Child Health, Child Growth, Neurocognitive Development, Sexual Maturation, Infectious Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,202 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Universidad de la Sabana, Foundation for Research in Nutrition and Health (FINUSAD)
- Study start
- 1 Feb 2006 (actual)
- Primary completion
- 11 Aug 2015 (actual)
- Study completion
- 11 Aug 2015 (actual)
- First posted
- 29 Sep 2017 (actual)
- 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.
This observational study investigates the associations of nutritional indicators, biomarkers, sociodemographic conditions, and infections with child health, as well as physical, behavioral, and cognitive development. Investigators recruited a random sample of 3202 children from primary public schools in Bogota, Colombia in February 2006 and followed them for a median of 6.5 years. Investigators hypothesized that poor nutritional status at the time of recruitment in middle childhood would be related to adverse health outcomes through adolescence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bogota School Children Cohort | – | –Children are classified according to exposure levels of: Micronutrient biomarker indicators: * Ferritin * Hemoglobin * Mean corpuscular volume * Zinc * Vitamin A * Vitamin B12 * Folate * Vitamin D Serum fatty acids Inflammatory biomarkers: * C-reactive protein Diet Socioeconomic status indicators Anthropometric indicators Incidence of infectious morbidity symptoms DNA biomarkers |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Children were selected from primary public schools in Bogota, Colombia.
Key inclusion criteria (1 listed)
- Primary public school enrollment in February 2006
Key exclusion criteria (1 listed)
- None
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
Externalizing behavior problems
Time frame: Assessed at one point in time when the children were 11-18 years old.
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The YSR is a self-administered questionnaire consisting of 112 statements addressing behaviors or feelings that adolescents rate as false, sometimes true, or very/often true. From responses to these questions, an Assessment Data Manager (ADM) software calculates continuous scores for aggressive behavior and rule breaking behavior. The sum of the aggressive and rule breaking behavior subscale scores constitute the total externalizing problems score.
Internalizing behavior problems
Time frame: Assessed at one point in time when the children were 11-18 years old.
Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The sum of the anxious/depressed, withdrawn/depressed, and somatic complaint subscale scores constitute the total internalizing problems score.
1 secondary outcome
Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)
Time frame: Assessed at one point in time when the children were 11-18 years old.
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 29 Sep 2017.
- Derived from this study: PubMed 29897579Robinson SL, Marin C, Oliveros H, Mora-Plazas M, Richards BJ, Lozoff B, Villamor E. Iron Deficiency, Anemia, and Low Vitamin B-12 Serostatus in Middle Childhood Are Associated with Behavior Problems in Adolescent Boys: Results from the Bogota School Children Cohort. J Nutr. 2018 May 1;148(5):760-770. doi: 10.1093/jn/nxy029.
- 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.
Eduardo Villamor, MD MPH DrPH principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition and Child Health, run by University of Michigan at 2 sites in Colombia.
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 1 inclusion and 1 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 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Externalizing behavior problems (time frame: Assessed at one point in time when the children were 11-18 years old.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297970, which also lists 1 linked publication.
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 29 Sep 2017.