Child Behavior ProblemNCT03283579
Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms
An observational study of Child Behavior Problem and Attention Deficit Hyperactivity Disorder, run by Barcelona Institute for Global Health.
Trial summary
This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA project, a population-based birth cohort in Spain. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Child Behavior Problem, Attention Deficit Hyperactivity Disorder, Fatty Acid Deficiency
- How many people
- 2,644 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Dec 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 4 to 8 years
- All sexes
- Child
Study population: This study was based on data from a population-based birth cohort, INMA (Infancia y Medio Ambiente [Environment and Childhood]) project, including four Spanish regions: Asturias (n=494) and Gipuzkoa (Basque Country) (n=638) on the Cantabrian coast, and Sabadell (Catalonia) (n=657) and Valencia (n=855) on the Mediterranean coast.
Who may be able to join
- Age 16 years or older
- Singleton pregnancy
- No use of assisted reproductive techniques
- Intention to deliver at the reference hospital
- Ability to speak and understand Spanish or a local language
Who cannot join
None listed.
About this study
Official title: Prenatal Omega-6/Omega-3 Ratio and Attention Deficit and Hyperactivity Disorder Symptoms in Children: a Population-based Longitudinal Study
This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was associated with higher subclinical ADHD symptoms during early and mid-childhood.
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
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 |
|---|---|---|
| Pregnant women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid ratio in cord blood
Measured: 2004-2008
ADHD 4 years old
Measured: 2008-2012
ADHD 7 years old
Measured: 2012-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study startNov 2003
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283579
- Sponsor's protocol ID
- mlopez
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Omega-6/Omega-3 Ratio and Attention Deficit and Hyperactivity Disorder Symptoms in Children: a Population-based Longitudinal Study
- ClinicalTrials.gov ID
- NCT03283579
- Acronym / sponsor ID
- mlopez
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,644 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Study start
- Nov 2003 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 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 study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was associated with higher subclinical ADHD symptoms during early and mid-childhood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | – |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- This study was based on data from a population-based birth cohort, INMA (Infancia y Medio Ambiente [Environment and Childhood]) project, including four Spanish regions: Asturias (n=494) and Gipuzkoa (Basque Country) (n=638) on the Cantabrian coast, and Sabadell (Catalonia) (n=657) and Valencia (n=855) on the Mediterranean coast.
Key inclusion criteria (5 listed)
- Age 16 years or older
- Singleton pregnancy
- No use of assisted reproductive techniques
- Intention to deliver at the reference hospital
- Ability to speak and understand Spanish or a local language
Key exclusion criteria (0 listed)
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
Fatty acid ratio in cord blood
Time frame: 2004-2008
ADHD 4 years old
Time frame: 2008-2012
ADHD 7 years old
Time frame: 2012-2016
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 18 Jun 2024.
- 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 Behavior Problem and Attention Deficit Hyperactivity Disorder, run by Barcelona Institute for Global Health.
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 5 inclusion and 0 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 18 Jun 2024. 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?
Fatty acid ratio in cord blood (time frame: 2004-2008). The study lists 3 primary outcomes in all. 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 18 Jun 2024.