Attention Deficit Hyperactivity Disorder (ADHD)ECOMEGANCT02248948
Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children
A study testing Omega-3 Fatty Acids and Medium Chain Triglycerides in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Laboratorios Ordesa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Omega-3 Fatty Acids and Medium Chain Triglycerides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.
Read the 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.
- Being tested
- Omega-3 Fatty Acids, Medium Chain Triglycerides
- Keywords
- Omega-3, ADHD, Quality of Life, Inattention, Hyperactivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDietary supplement
Also called EPA/DHA
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 TriglyceridesDietary supplement
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Omega-3 Fatty Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and at 6 months
Secondary outcomes (4)
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.
Measured: At baseline and at 6 months
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.
Measured: At baseline and at 6 months
Changes in Children's Quality of Life
Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)
Measured: At baseline and at 6 months
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)
Measured: At baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Responsible party
- Sponsor
- Investigators
- Jordi Sasot Llevadot, MD, Principal investigator, Centro Médico TeknonAna Bielsa, MD, Study chair, Unidad Clínica Familianova ScholaMiquel Sisteré, MD, Study chair, Centre de Salut Mental Infanto-Juvenil, LleidaEsther Cardo Jalón, MD, Study chair, Unidad Pediártica Balear, Palma de MallorcaIsabel Hernández Otero, MD, Study chair, Hospital Universitario Virgen de la Victoria, Málaga.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248948
- Sponsor's protocol ID
- ECOMEGA-TDAH-014
- Other IDs
- 2013-004638-14
- Acronym
- ECOMEGA
- Status last verified
- Jul 2019
- First submitted
- 22 Sep 2014
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37058600
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02248948
- Acronym / sponsor ID
- ECOMEGA / ECOMEGA-TDAH-014
- Keywords
- Omega-3, ADHD, Quality of Life, Inattention, Hyperactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium Chain Triglycerides Supplement | Placebo comparator | Dietary Supplement: Medium Chain TriglyceridesMedium Chain Triglycerides Oil with 5 micrograms of Vitamin D and 6 mg of Vitamin E in 4 ml. |
| Omega-3 Fatty Acids Supplement | Experimental | Dietary Supplement: Omega-3 Fatty AcidsThe 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidsAlso: EPA/DHAPatients 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. | Dietary supplement | Omega-3 Fatty Acids Supplement |
| Medium Chain TriglyceridesAlso: PlaceboPatients 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. | Dietary supplement | Medium Chain Triglycerides Supplement |
Primary outcome
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
4 secondary outcomes
Changes in neuropsychological outcomes
Time frame: At baseline and at 6 months
Changes in emotional outcomes
Time frame: At baseline and at 6 months
Changes in Children's Quality of Life
Time frame: At baseline and at 6 months
Changes in Quality of Life of Parents of Children with ADHD
Time frame: At baseline and at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 37058600Gillies 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Sasot Llevadot, MD principal investigator
Centro Médico Teknon
Ana Bielsa, MD study chair
Unidad Clínica Familianova Schola
Miquel Sisteré, MD study chair
Centre de Salut Mental Infanto-Juvenil, Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids and Medium Chain Triglycerides in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Laboratorios Ordesa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in clinical symptoms of ADHD (time frame: At baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.