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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acids
* Dietary Supplement: Medium Chain Triglycerides


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Medium Chain Triglycerides Supplement<br>Medium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml. | Dietary Supplement: Medium Chain Triglycerides<br>* 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.<br>* Other names: Placebo;|
| Experimental: Omega-3 Fatty Acids Supplement<br>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<br>* 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.<br>* Other names: EPA/DHA;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3, ADHD, Quality of Life, Inattention, Hyperactivity