NCT03283579

Brief 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. Higher cord blood n-6:n-3 ratio was associated with higher subclinical ADHD symptoms during early and mid-childhood.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,644

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
Last Updated

June 18, 2024

Status Verified

September 1, 2017

Enrollment Period

12.1 years

First QC Date

September 13, 2017

Last Update Submit

June 17, 2024

Conditions

Child Behavior ProblemAttention Deficit Hyperactivity DisorderFatty Acid Deficiency

Outcome Measures

Primary Outcomes (3)

  • Fatty acid ratio in cord blood

    2004-2008

  • ADHD 4 years old

    2008-2012

  • ADHD 7 years old

    2012-2016

Study Arms (1)

Pregnant women

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 14, 2017

Study Start

November 1, 2003

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 18, 2024

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share