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

NCT ID: NCT02248948

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-07-31

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Medium Chain Triglycerides Supplement

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

Group Type: PLACEBO_COMPARATOR

Medium Chain Triglycerides

Intervention Type: DIETARY_SUPPLEMENT

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.

Omega-3 Fatty Acids Supplement

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.

Group Type: EXPERIMENTAL

Omega-3 Fatty Acids

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

EPA/DHA; Placebo

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clever Instruments S.L.

INDUSTRY

Sponsor Role: collaborator

Laboratorios Ordesa

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordi Sasot Llevadot, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Médico Teknon

Ana Bielsa, MD

Role: STUDY_CHAIR

Unidad Clínica Familianova Schola

Miquel Sisteré, MD

Role: STUDY_CHAIR

Centre de Salut Mental Infanto-Juvenil, Lleida

Esther Cardo Jalón, MD

Role: STUDY_CHAIR

Unidad Pediártica Balear, Palma de Mallorca

Isabel Hernández Otero, MD

Role: STUDY_CHAIR

Hospital Universitario Virgen de la Victoria, Málaga.

Locations

Centro Médico Teknon

Barcelona, , Spain

Countries

Spain

References

Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

Reference Type: DERIVED

PMID: 37058600 (View on PubMed)

Other Identifiers

2013-004638-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ECOMEGA-TDAH-014

Identifier Type: -

Identifier Source: org_study_id