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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
Sponsor:
Collaborator:
Engelhard Arzneimittel GmbH & Co.KG
Information provided by (Responsible Party):
Prof. Huss, Johannes Gutenberg University Mainz

Brief Summary:
This study will determine the nutritional efficacy of Polyunsaturated Fatty Acids (PUFAs) in combination with zinc and magnesium, in children and adolescents diagnosed with Attention Deficit/ Hyperactivity Disorder (ADHD). The nutritional efficacy has to be proven in agreement with the German "Verordnung über Diätetische Lebensmittel (DiätV)" and the corresponding European Directive 1999/21/EC. This objective is reached by performing a placebo-controlled supplementation study with a main efficacy criterion which is also being used in pivotal studies of stimulant and non-stimulant drugs, i.e. the treatment differences between final visit and baseline in the Attention Deficit Hyperactivity Disorder Rating Scale, Parent Version IV (ADHDRS-IV).

Condition or disease Intervention/treatment Phase
ADHD Dietary Supplement: ω-3 fatty acids suspension Dietary Supplement: placebo suspension Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • Esprico(R) suspension
  • 2 verum to 1 placebo

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Continuous Performance Test (CPT) [ Time Frame: change from Baseline to end of treatment, an expected average of 84 days ]
    Differences in Continuous Performance Test.

  4. Nutrition protocol [ Time Frame: baseline ]
    Assessment of diet habits.

  5. 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.

  6. 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,...



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written Informed Consent by parents and patients (separately for age groups 6 - 11 years and 12 - 17 years)
  • Children and adolescents of both gender in the age group between 6 and 17 years
  • Confirmed diagnosis of ADHD by semi-structured clinical interview Kiddie Schedule for Affective Disorders and Schizophrenia for school-age children (K-SADS)
  • ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored ≥24
  • Sufficient knowledge of the German language

Exclusion Criteria:

  • Known hypersensitivity against components of either the verum or placebo food
  • All serious internal diseases
  • All severe psychiatric diseases except oppositional defiant disorders
  • Current intake of the following medication: antidepressants and other psychotropic medication
  • Recent intake of ω-3 fatty acids supplementation
  • Indication for hospitalization
  • Suicidality (including suicidal thoughts)
  • intelligence quotient < 70
  • Previous medication with stimulants within 4 weeks
  • Placement in an institution on official or judicial ruling
  • Lack of willingness to store and transmit pseudonym data according to German regulations
  • Parallel participation in another trial, or less than 4 weeks ago
  • Patients foreseeable requiring a primary medication with methylphenidate during the study period of 12 weeks

Information from the National Library of Medicine

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


Locations
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Germany
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
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Engelhard Arzneimittel GmbH & Co.KG
Investigators
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Principal Investigator: Michael Huss, Prof. Dr. University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry

Publications:
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Responsible Party: Prof. Huss, Michael Huss, Prof. Dr., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01340690     History of Changes
Other Study ID Numbers: PAD-EA-10-01-067
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof. Huss, Johannes Gutenberg University Mainz:
ADHD
children
adolescents
Polyunsaturated Fatty Acids
ADHDRS - IV

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders