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

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Interventions: Dietary Supplement: Medium Chain Triglycerides; Dietary Supplement: Omega-3 Fatty Acids

• Registration Number: NCT02248948
• Lead Sponsor: Laboratorios Ordesa

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-25
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium Chain Triglycerides Supplement	Medium Chain Triglycerides	Medium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.
Omega-3 Fatty Acids Supplement	Omega-3 Fatty Acids	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.

Primary Outcome Measures

Name	Time	Method
Improvement in clinical symptoms of ADHD	At baseline and at 6 months	Differences between groups measured by: 1. Number of criteria of the ADHD-Scale-IV rated by parents and teachers; 2. Clinical Global Impressions Scale (CGI) assessed by the physician

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centro Médico Teknon; 🇪🇸 Barcelona, Spain