Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder (PAD)
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|ClinicalTrials.gov Identifier: NCT01340690|
Recruitment Status : Terminated (The sample size of the planned interims analysis was achieved)
First Posted : April 22, 2011
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Dietary Supplement: ω-3 fatty acids suspension Dietary Supplement: placebo suspension||Phase 3|
The syndrome of ADHD affects 5-6% of the children and adolescents worldwide. The hallmarks are inattention, impulsivity and hyperactivity. Due to parent's fear of significant adverse effects caused by stimulant or non-stimulant therapy a high degree of children with ADHD remains untreated. Recent observational studies showed that ADHD is often associated with decreased nutritional status of certain PUFAs, zinc and magnesium which might be due to metabolic disturbances in the case of fatty acids. First interventional studies revealed that a supplementation of these nutrients may affect ADHD-related disorders and might improve certain clinical parameters, such as concentration.
Participants will be randomly assigned to receive either a nutritional supplement or placebo once a day for the duration of 84 days. Participants will come in for the assessment of ADHD symptoms, compliance and the assessment of secondary outcome variables. Side effects will be monitored continuously and also assessed by rating scales.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We use the dietary supplementation like a medication and performed the study like a phase 3 medication study, because the dietary supplementation (verum) is available as special preparation in drug stores.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The verum "nutrional supplementation" is completely masked and an appropriate Placebo is provided. Up to know, none of the above mentioned is unblinded|
|Official Title:||PAD-study: Nutritional Efficacy of Polyunsaturated Fatty Acids (Omega-3 and Omega-6) in Combination With Zinc and Magnesium Versus Placebo in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder (ADHD)|
|Actual Study Start Date :||March 8, 2011|
|Actual Primary Completion Date :||March 31, 2016|
|Actual Study Completion Date :||March 1, 2017|
Active Comparator: ω-3 fatty acids suspension
2 bags of Esprico(R) suspension each day. Each 4ml suspension bag includes 400mg eicosapentaenoic acid (EPA), 40mg docosahexaenoic acid (DHA), 5.4 mg gamma-linolenic acid (GLA), 80 mg magnesium, 5 mg zinc and consists of linseed oil, xylitol, sea fish oil with high portion of omega-3-acids, magnesium citrate, vegetable oil, orange flavour, evening primrose oil, zink gluconate, soya lecithin, citric acid, acesulfame k (E950)
Dietary Supplement: ω-3 fatty acids suspension
2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days
Placebo Comparator: placebo suspension
2 bags of Esprico (R) placebo suspension. Includes no ω-3 fatty acids, no ω-6 fatty acids, no magnesium and no zinc, but other vegetable oils, orange flavor, etc.
Dietary Supplement: placebo suspension
suspension to mimic verum Esprico (R) suspension. 2 bags of Esprico(R) placebo suspension given orally once daily in the morning for 84 days
- ADHDRS - IV [ Time Frame: Difference in total score between baseline and end of study, an expected average of 84 days ]The primary outcome measure for efficacy will be the absolute change in the ADHDRS total score between baseline and day 84 of randomized treatment.
- Barkley´s Side Effects Rating Scale [ Time Frame: Baseline and each visit, monthly, an expected average of 84 days in total ]Number of Participants with Adverse Events.
- Montgomery-Åsberg-Depression Rating Scale (MADRS) [ Time Frame: Baseline and each visit, monthly, an expected average of 84 days in total ]Assessment of Symptoms of Depression.
- Continuous Performance Test (CPT) [ Time Frame: change from Baseline to end of treatment, an expected average of 84 days ]Differences in Continuous Performance Test.
- Nutrition protocol [ Time Frame: baseline ]Assessment of diet habits.
- Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) [ Time Frame: change from Baseline to end of treatment, an expected average of 84 days ]Assessment of Symptoms of ADHD and to what degree individual's behavior or emotional problems have impacted various clinically relevant domains of functioning.
- PUFA associated blood parameters [ Time Frame: change from Baseline to end of treatment, an expected average of 84 days ]complete fatty acid profile in red blood cells and relevant ratios, e.g. Omega-HS-Index, Plasma-Zinc, Plasma-Copper, Serum-Magnesium, Serum-Ferritin,...
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340690
|DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik|
|Bad Neuenahr, Germany, D 53474|
|Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters|
|Berlin, Germany, D 13353|
|University Medicine Mainz|
|Mainz, Germany, D 55131|
|Kinderzentrum Maulbronn gGmbH|
|Maulbronn, Germany, D 75433|
|Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied|
|Neuwied, Germany, D 56564|
|Principal Investigator:||Michael Huss, Prof. Dr.||University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry|