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Status unknownNCT00770627Updated Apr 13, 2010

Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

A Phase 4 interventional study of Omega 3 caps in Attention Deficit Hyperactivity Disorder, sponsored by Laboratoires URGO. Status unknown at 2 sites in France. Open to participants aged 6 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-04-13.

Sponsored by Laboratoires URGO · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2010), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
6 Years to 15 Years
Sex
All
01

Study summary

Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.

The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • 160 children
  • parallel group
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's planned enrollment of 160 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Laboratoires URGO is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 6 to 15 years and 11 months of age ADHD children with hyperactivity confirmed dy DSM IV criteria Children and parents' consent

Exclusion criteria

Exclusion Criteria:

  • Without methylphenidate treatment Fish or other sea products allergic Intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial Children need quickly to take methylphenidate: social, family, or school risk Intake methylphenidate 30 days before the trial or/and intake it during one consecutive week
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Placebo comparator
    Placebo caps

    Dietary Supplement: Omega 3 caps

  • Active comparator
    Omega 3 caps

    Dietary Supplement: Omega 3 caps

Interventions

  • Dietary supplementOmega 3 caps

    Children between 6 and 8 years must take 2 caps/day Children between 9 and 11 years must take 3 caps/day Children between 12 and 15 years must take 4 caps /day

06

What researchers measure

Primary outcomes

  1. ADHD rating scale

    Time frame: 5 minutes

Secondary outcomes

  1. Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity)

    Time frame: 3 hours

07

Study locations

2 sites
  • Clinical Investigation Center
    Bron, 69677, France
  • Hopital Cardiovasculaire Louis Pradel
    Bron, 69677, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00770627
Lead sponsor
Laboratoires URGO
First posted
Oct 10, 2008
Start date
Oct 2008
Primary completion
Jul 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Apr 13, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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