Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004638-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clever Instruments S.L. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acids | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical symptoms of ADHD | Differences between groups measured by:
| At baseline and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and at 6 months |
| Changes in emotional outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in nutritional status | Differences between groups measured by anthropometry and feeding scale of the Health National Survey (National Statistical Institute, Spain). | At baseline and at 2, 4 and 6 months |
| Tolerability of study product |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jordi Sasot Llevadot, MD | Centro Médico Teknon | Principal Investigator |
| Ana Bielsa, MD | Unidad Clínica Familianova Schola | Study Chair |
| Miquel Sisteré, MD | Centre de Salut Mental Infanto-Juvenil, Lleida | Study Chair |
| Esther Cardo Jalón, MD | Unidad Pediártica Balear, Palma de Mallorca | Study Chair |
| Isabel Hernández Otero, MD | Hospital Universitario Virgen de la Victoria, Málaga. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Teknon | Barcelona | 08017 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37058600 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020879 | Neuromuscular Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Medium Chain Triglycerides | Dietary Supplement | 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. |
|
|
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. |
| 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) | 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) | At baseline and at 6 months |
Differences between groups measured by product acceptability.
| At 2, 4 and 6 months |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |