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

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

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Dietary supplement: Medium Chain Triglycerides; Dietary supplement: Omega-3 Fatty Acids

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08017
    • Centro Médico Teknon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Medium Chain Triglycerides Supplement; Medium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.	Dietary supplement: Medium Chain Triglycerides; 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
Experimental: Omega-3 Fatty Acids Supplement; The Omega-3 Fatty Acid supplement provides 540 mg of eicosapentaenoic acid (EPA), 340 mg of docosahexaenoic acid (DHA), 60 mg of gamma linolenic acid (GLA/Omega-6), 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.	Dietary supplement: Omega-3 Fatty Acids; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in clinical symptoms of ADHD	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	At baseline and at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in neuropsychological outcomes	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.	At baseline and at 6 months
Changes in emotional outcomes	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.	At baseline and at 6 months
Changes in Children's Quality of Life	Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)	At baseline and at 6 months
Changes in Quality of Life of Parents of Children with ADHD	Differences between groups measured with a Short Version of the World Health Organization Quality of Life Instruments (WHOQoL)	At baseline and at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in nutritional status	Differences between groups measured by anthropometry and feeding scale of the Health National Survey (National Statistical Institute, Spain).	At baseline and at 2, 4 and 6 months
Tolerability of study product	Differences between groups measured by product acceptability.	At 2, 4 and 6 months

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: Clever Instruments S.L.
• Investigators: Principal Investigator: Jordi Sasot Llevadot, MD, Centro Médico Teknon; Study Chair: Ana Bielsa, MD, Unidad Clínica Familianova Schola; Study Chair: Miquel Sisteré, MD, Centre de Salut Mental Infanto-Juvenil, Lleida; Study Chair: Esther Cardo Jalón, MD, Unidad Pediártica Balear, Palma de Mallorca; Study Chair: Isabel Hernández Otero, MD, Hospital Universitario Virgen de la Victoria, Málaga.

Publications and helpful links

Helpful Links

• Spanish Pediatric Association (AEP) Congress 2015 - Poster Book - pg.287

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: September 22, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; ADHD; Omega-3; Hyperactivity; Inattention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: ECOMEGA-TDAH-014; 2013-004638-14 (EudraCT Number)