- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283579
Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms
September 6, 2018 updated by: Barcelona Institute for Global Health
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
2644
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Pregnant women
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fatty acid ratio in cord blood
Time Frame: 2004-2008
|
2004-2008
|
ADHD 4 years old
Time Frame: 2008-2012
|
2008-2012
|
ADHD 7 years old
Time Frame: 2012-2016
|
2012-2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2003
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 13, 2017
First Submitted That Met QC Criteria
September 13, 2017
First Posted (Actual)
September 14, 2017
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
September 6, 2018
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mlopez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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