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

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

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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