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

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ClinicalTrials.gov Identifier: NCT02248948
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : August 8, 2016
Sponsor:
Collaborator:
Clever Instruments S.L.
Information provided by (Responsible Party):
Laboratorios Ordesa

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Dietary Supplement: Omega-3 Fatty Acids Dietary Supplement: Medium Chain Triglycerides Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Placebo Comparator: Medium Chain Triglycerides Supplement
Medium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml.
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 Name: Placebo

Experimental: 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.
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 Name: EPA/DHA




Primary Outcome Measures :
  1. Improvement in clinical symptoms of ADHD [ Time Frame: At baseline and at 6 months ]

    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


Secondary Outcome Measures :
  1. Changes in neuropsychological outcomes [ Time Frame: At baseline and at 6 months ]
    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.

  2. Changes in emotional outcomes [ Time Frame: At baseline and at 6 months ]
    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.

  3. Changes in Children's Quality of Life [ Time Frame: At baseline and at 6 months ]
    Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)

  4. Changes in Quality of Life of Parents of Children with ADHD [ Time Frame: At baseline and at 6 months ]
    Differences between groups measured with a Short Version of the World Health Organization Quality of Life Instruments (WHOQoL)


Other Outcome Measures:
  1. Changes in nutritional status [ Time Frame: At baseline and at 2, 4 and 6 months ]
    Differences between groups measured by anthropometry and feeding scale of the Health National Survey (National Statistical Institute, Spain).

  2. Tolerability [ Time Frame: At 2, 4 and 6 months ]
    Differences between groups measured by product acceptability.



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248948


Locations
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Spain
Centro Médico Teknon
Barcelona, Spain, 08017
Sponsors and Collaborators
Laboratorios Ordesa
Clever Instruments S.L.
Investigators
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Principal Investigator: Jordi Sasot Llevadot, MD Centro Médico Teknon
Study Chair: 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 Unidad de Salud Mental Infato-Juvenil, Hospital Universitario Virgen de la Victoria, Málaga.

Additional Information:
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Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT02248948     History of Changes
Other Study ID Numbers: ECOMEGA-TDAH-014
2013-004638-14 ( EudraCT Number )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016

Keywords provided by Laboratorios Ordesa:
Omega-3
ADHD
Quality of Life
Inattention
Hyperactivity

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms