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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

— ECOMEGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248948
• Other study ID #: ECOMEGA-TDAH-014
• Secondary ID: 2013-004638-14
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Centro Médico Teknon	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Clever Instruments S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Tolerability of study product	Differences between groups measured by product acceptability.	At 2, 4 and 6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

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