Clinical trial NCT02248948: Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children
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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Omega-3
ADHD
Quality of Life
Inattention
Hyperactivity
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Clever Instruments S.L.
First posted: 2014-09-25
Enrollment: 231
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in clinical symptoms of ADHD
timeFrame: At baseline and at 6 months
Secondary outcomes:
measure: Changes in neuropsychological outcomes
timeFrame: At baseline and at 6 months
measure: Changes in emotional outcomes
timeFrame: At baseline and at 6 months
measure: Changes in Children's Quality of Life
timeFrame: At baseline and at 6 months
measure: Changes in Quality of Life of Parents of Children with ADHD
timeFrame: At baseline and at 6 months
Other outcomes:
measure: Changes in nutritional status
timeFrame: At baseline and at 2, 4 and 6 months
measure: Tolerability of study product
timeFrame: At 2, 4 and 6 months
Locations:
city: Barcelona
country: Spain
facility: Centro Médico Teknon
Study officials:
affiliation: Centro Médico Teknon
name: Jordi Sasot Llevadot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad Clínica Familianova Schola
name: Ana Bielsa, MD
role: STUDY_CHAIR
affiliation: Centre de Salut Mental Infanto-Juvenil, Lleida
name: Miquel Sisteré, MD
role: STUDY_CHAIR
affiliation: Unidad Pediártica Balear, Palma de Mallorca
name: Esther Cardo Jalón, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario Virgen de la Victoria, Málaga.
name: Isabel Hernández Otero, MD
role: STUDY_CHAIR
References: