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

NCT02248948 | Completed DMC

• 2 other identifiers: ECOMEGA-TDAH-0142013-004638-14
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Omega-3; ADHD; Quality of Life; Inattention; Hyperactivity

Outcome Measures

Primary Outcomes (1)

• Improvement in clinical symptoms of ADHD

  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

  At baseline and at 6 months

Secondary Outcomes (4)

• Changes in neuropsychological outcomes

  At baseline and at 6 months

• Changes in emotional outcomes

  At baseline and at 6 months

• Changes in Children's Quality of Life

  At baseline and at 6 months

• Changes in Quality of Life of Parents of Children with ADHD

  At baseline and at 6 months

Other Outcomes (2)

• Changes in nutritional status

  At baseline and at 2, 4 and 6 months

• Tolerability of study product

  At 2, 4 and 6 months

Study Arms (2)

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.

Dietary Supplement: Medium Chain Triglycerides

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.

Dietary Supplement: Omega-3 Fatty Acids

Interventions

Omega-3 Fatty Acids 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.

Also known as: EPA/DHA

Omega-3 Fatty Acids Supplement

Medium Chain Triglycerides 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.

Also known as: Placebo

Medium Chain Triglycerides Supplement

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Ordesa: lead
• Clever Instruments S.L.: collaborator

Study Sites (1)

Centro Médico Teknon

Barcelona, 08017, Spain

Location

Related Publications (1)

• 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.

  PMID: 37058600 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Jordi Sasot Llevadot, MD

  Centro Médico Teknon

  PRINCIPAL INVESTIGATOR

• Ana Bielsa, MD

  Unidad Clínica Familianova Schola

  STUDY CHAIR

• Miquel Sisteré, MD

  Centre de Salut Mental Infanto-Juvenil, Lleida

  STUDY CHAIR

• Esther Cardo Jalón, MD

  Unidad Pediártica Balear, Palma de Mallorca

  STUDY CHAIR

• Isabel Hernández Otero, MD

  Hospital Universitario Virgen de la Victoria, Málaga.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

ES (1)