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

Laboratorios Ordesa

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Dietary Supplement: Omega-3 Fatty Acids; Dietary Supplement: Medium Chain Triglycerides

Study type: Interventional

Funder types: Industry

Identifiers

NCT02248948

ECOMEGA-TDAH-014

2013-004638-14 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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231 participants in 2 patient groups, including a placebo group

Medium Chain Triglycerides Supplement

Placebo Comparator group

Description:

Medium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.

Treatment:

Dietary Supplement: Medium Chain Triglycerides

Omega-3 Fatty Acids Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Omega-3 Fatty Acids