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Completed

NCT Number: NCT02248948

Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children

This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Médico Teknon

Barcelona, 08017, Spain

About this study

This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of an Omega-3 Fatty Acid Supplement with EPA, DHA, vitamins E and D on ADHD clinical symptoms (according to Diagnostic and Statistical Manual for Mental Disorders, 4th. edition (DSM-IV-TR) criteria) in children between 6 and 11 years. Patients will be randomized to receive either the new omega-3 supplement or a placebo during 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 6 and 11 years 11 months.
  • ADHD diagnosis according to DSM-IV-TR criteria
  • Children whose parents are able to reliably meet all visits and all the tests required for this study based on the researcher judgment
  • Patient representative (either parents or legal guardians) must understand the conditions of the study and sign the informed consent

Exclusion criteria

  • Patients who do not meet diagnostic criteria for ADHD
  • Patients with a previously known allergy or intolerance to the components of Omega- 3 supplement
  • Patients with underlying diseases that, according to medical criteria , are not eligible for supplementation with Omega-3 fatty acids : fatty liver disease (or other liver disease), bleeding disorders and cardiovascular disease
  • Patients with allergies to fish and /or shellfish
  • Patients who have received ADHD pharmacological treatment or fatty acid supplements at any dose for more than 7 consecutive days within the last 3 months
  • Patients who have received psychological or psycho-educational treatment in the past 3 months
  • Patients who have had some kind of psychometric diagnostic tests in the last year
  • Patients with scores corresponding to a lower mental age (more than 1 year less) according to the Wechsler Intelligence Cubes Scale for Children (WISC-IV)
  • Patients with severe emotional problems according to the CAS or STAIC tests
  • Patients participating in another clinical trial

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.

Other names: EPA/DHA

Medium chain triglycerides

Dietary Supplement

Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.

Other names: Placebo

Primary outcomes

  1. Improvement in clinical symptoms of ADHD

    Time frame: At baseline and at 6 months

    Differences between groups measured by:

    • Number of criteria of the ADHD-Scale-IV rated by parents and teachers
    • Clinical Global Impressions Scale (CGI) assessed by the physician

Secondary outcomes

  1. Changes in neuropsychological outcomes

    Time frame: At baseline and at 6 months

    Differences between groups measured by Scores of the Conners Continuous Performance Test-II (CPT-II) which evaluate potential problems related to executive functions perception, internal ordering, working memory, motor control.

  2. Changes in emotional outcomes

    Time frame: At baseline and at 6 months

    Differences between groups measured by Cognitive Assessment System (CAS) for children between 6-8 years old and by State-Trait Anxiety Inventory for Children (STAIC) for children between 9-12 years old.

  3. Changes in Children's Quality of Life

    Time frame: At baseline and at 6 months

    Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)

  4. Changes in Quality of Life of Parents of Children with ADHD

    Time frame: At baseline and at 6 months

    Differences between groups measured with a Short Version of the World Health Organization Quality of Life Instruments (WHOQoL)

Other outcomes

  1. Changes in nutritional status

    Time frame: At baseline and at 2, 4 and 6 months

    Differences between groups measured by anthropometry and feeding scale of the Health National Survey (National Statistical Institute, Spain).

  2. Tolerability of study product

    Time frame: At 2, 4 and 6 months

    Differences between groups measured by product acceptability.

Sponsors and collaborators

Lead sponsor

Laboratorios Ordesa

Industry

Collaborators

  • Clever Instruments S.L.

Registry information

Official study title

Multicenter Randomized Controlled Trial for the Evaluation of Superiority of a Supplement With Omega-3 Fatty Acids Versus Placebo for the Improvement of Attention Deficit and Hyperactivity Disorder (ADHD) in Children

Acronym: ECOMEGA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2014
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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