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

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Omega-3 Fatty Acids

Medium Chain Triglycerides

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring Omega-3, ADHD, Quality of Life, Inattention, Hyperactivity

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro Médico Teknon

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Medium Chain Triglycerides Supplement

Omega-3 Fatty Acids Supplement

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Changes in Children's Quality of Life

Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)

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)

Full Information

NCT ID

NCT02248948

First Posted

September 22, 2014

Last Updated

July 17, 2019

Sponsor

Laboratorios Ordesa

Collaborators

Clever Instruments S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02248948

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Ordesa

Collaborators

Clever Instruments S.L.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

231 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medium Chain Triglycerides Supplement

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Omega-3 Fatty Acids Supplement

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 Fatty Acids

Other Intervention Name(s)

EPA/DHA

Intervention Description

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

Intervention Name(s)

Medium Chain Triglycerides

Other Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improvement in clinical symptoms of ADHD

Description

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

Time Frame

At baseline and at 6 months

Secondary Outcome Measure Information:

Title

Changes in neuropsychological outcomes

Description

Time Frame

At baseline and at 6 months

Title

Changes in emotional outcomes

Description

Time Frame

At baseline and at 6 months

Title

Changes in Children's Quality of Life

Description

Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)

Time Frame

At baseline and at 6 months

Title

Changes in Quality of Life of Parents of Children with ADHD

Description

Differences between groups measured with a Short Version of the World Health Organization Quality of Life Instruments (WHOQoL)

Time Frame

At baseline and at 6 months

Other Pre-specified Outcome Measures:

Title

Changes in nutritional status

Description

Differences between groups measured by anthropometry and feeding scale of the Health National Survey (National Statistical Institute, Spain).

Time Frame

At baseline and at 2, 4 and 6 months

Title

Tolerability of study product

Description

Differences between groups measured by product acceptability.

Time Frame

At 2, 4 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

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

Overall Study Officials: