Status:
COMPLETED
Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children
Lead Sponsor:
Laboratorios Ordesa
Collaborating Sponsors:
Clever Instruments S.L.
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
6-11 years
Phase:
NA
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 clinic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT02248948
Start Date
September 1 2014
End Date
July 1 2016
Last Update
July 19 2019
Active Locations (1)
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1
Centro Médico Teknon
Barcelona, Spain, 08017