Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Keywords
Omega-3, ADHD, Quality of Life, Inattention, Hyperactivity
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.
Interventions
DIETARY_SUPPLEMENTOmega-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.
DIETARY_SUPPLEMENTMedium 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.
Sponsors
Clever Instruments S.L.
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in clinical symptoms of ADHD | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in neuropsychological outcomes | 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. |
| Changes in emotional outcomes | 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. |
| Changes in Children's Quality of Life | At baseline and at 6 months | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in nutritional status | 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). |
| Tolerability of study product | At 2, 4 and 6 months | Differences between groups measured by product acceptability. |
Countries
Spain
Outcome results
None listed