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Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents

NCT01219309 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2010-10-13

No results posted yet for this study

Summary

Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in children and adolescents.

Method: Randomized placebo-controlled one-way crossover trial with 75 children and adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3 months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom severity and impairment.

Conditions

  • ADHD
  • Reading/Writing Disorder

Interventions

DIETARY_SUPPLEMENT

Omega 3/6 fatty acids

3 capsules bid orally

DIETARY_SUPPLEMENT

Placebo (olive oil)

3 capsules bid orally

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • Göteborg University

    lead OTHER

Principal Investigators

  • Mats Johnson, MD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2006-06-30
Completion
2007-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219309 on ClinicalTrials.gov