Trial | NCT02248948  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    231
This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.
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 Started
Sep 30
2014
Primary Completion
Jul 31
2016
Study Completion
Jul 31
2016
Last Update
Jul 19
2019

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

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

Medium Chain Triglycerides Supplement Placebo Comparator

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

Omega-3 Fatty Acids Supplement Experimental

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.

Criteria 

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
No Results Posted