Fatty Acids and Attention Deficit and Hyperactivity Disor... | NCT03283579

Studies
Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms

NCT03283579

Sponsor

Barcelona Institute for Global Health

Status

Completed

Last Update Posted

Jun 18, 2024Actual

Enrollment

2,644Actual

Phase

Not provided

Conditions

Child Behavior Problem
Attention Deficit Hyperactivity Disorder
Fatty Acid Deficiency

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 13, 2017

First Submission Date that Met QC Criteria

Sep 13, 2017

First Posted Date

Sep 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2024

Last Update Posted Date

Jun 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,644Actual

Label	Type	Description	Intervention Names
Pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatty acid ratio in cord blood		2004-2008
ADHD 4 years old		2008-2012
ADHD 7 years old		2012-2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

8 Years

Standard Ages

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.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided