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Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder (PAD)

Primary Purpose

ADHD

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
ω-3 fatty acids suspension
placebo suspension
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, children, adolescents, Polyunsaturated Fatty Acids, ADHDRS - IV

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik
  • Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
  • University Medicine Mainz
  • Kinderzentrum Maulbronn gGmbH
  • Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ω-3 fatty acids suspension

placebo suspension

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

ADHDRS - IV
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

Barkley´s Side Effects Rating Scale
Number of Participants with Adverse Events.
Montgomery-Åsberg-Depression Rating Scale (MADRS)
Assessment of Symptoms of Depression.
Continuous Performance Test (CPT)
Differences in Continuous Performance Test.
Nutrition protocol
Assessment of diet habits.
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
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
complete fatty acid profile in red blood cells and relevant ratios, e.g. Omega-HS-Index, Plasma-Zinc, Plasma-Copper, Serum-Magnesium, Serum-Ferritin,...

Full Information

First Posted
April 7, 2011
Last Updated
September 19, 2017
Sponsor
Johannes Gutenberg University Mainz
Collaborators
Engelhard Arzneimittel GmbH & Co.KG
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1. Study Identification

Unique Protocol Identification Number
NCT01340690
Brief Title
Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder
Acronym
PAD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
The sample size of the planned interims analysis was achieved
Study Start Date
March 8, 2011 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
Engelhard Arzneimittel GmbH & Co.KG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, children, adolescents, Polyunsaturated Fatty Acids, ADHDRS - IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ω-3 fatty acids suspension
Arm Type
Active Comparator
Arm Description
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)
Arm Title
placebo suspension
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
ω-3 fatty acids suspension
Other Intervention Name(s)
Esprico(R) suspension, 2 verum to 1 placebo
Intervention Description
2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo suspension
Intervention Description
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 Measure Information:
Title
ADHDRS - IV
Description
The primary outcome measure for efficacy will be the absolute change in the ADHDRS total score between baseline and day 84 of randomized treatment.
Time Frame
Difference in total score between baseline and end of study, an expected average of 84 days
Secondary Outcome Measure Information:
Title
Barkley´s Side Effects Rating Scale
Description
Number of Participants with Adverse Events.
Time Frame
Baseline and each visit, monthly, an expected average of 84 days in total
Title
Montgomery-Åsberg-Depression Rating Scale (MADRS)
Description
Assessment of Symptoms of Depression.
Time Frame
Baseline and each visit, monthly, an expected average of 84 days in total
Title
Continuous Performance Test (CPT)
Description
Differences in Continuous Performance Test.
Time Frame
change from Baseline to end of treatment, an expected average of 84 days
Title
Nutrition protocol
Description
Assessment of diet habits.
Time Frame
baseline
Title
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Description
Assessment of Symptoms of ADHD and to what degree individual's behavior or emotional problems have impacted various clinically relevant domains of functioning.
Time Frame
change from Baseline to end of treatment, an expected average of 84 days
Title
PUFA associated blood parameters
Description
complete fatty acid profile in red blood cells and relevant ratios, e.g. Omega-HS-Index, Plasma-Zinc, Plasma-Copper, Serum-Magnesium, Serum-Ferritin,...
Time Frame
change from Baseline to end of treatment, an expected average of 84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Huss, Prof. Dr.
Organizational Affiliation
University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik
City
Bad Neuenahr
ZIP/Postal Code
D 53474
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
City
Berlin
ZIP/Postal Code
D 13353
Country
Germany
Facility Name
University Medicine Mainz
City
Mainz
ZIP/Postal Code
D 55131
Country
Germany
Facility Name
Kinderzentrum Maulbronn gGmbH
City
Maulbronn
ZIP/Postal Code
D 75433
Country
Germany
Facility Name
Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied
City
Neuwied
ZIP/Postal Code
D 56564
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19672626
Citation
Schuchardt JP, Huss M, Stauss-Grabo M, Hahn A. Significance of long-chain polyunsaturated fatty acids (PUFAs) for the development and behaviour of children. Eur J Pediatr. 2010 Feb;169(2):149-64. doi: 10.1007/s00431-009-1035-8. Epub 2009 Aug 12.
Results Reference
background
PubMed Identifier
20868469
Citation
Huss M, Volp A, Stauss-Grabo M. Supplementation of polyunsaturated fatty acids, magnesium and zinc in children seeking medical advice for attention-deficit/hyperactivity problems - an observational cohort study. Lipids Health Dis. 2010 Sep 24;9:105. doi: 10.1186/1476-511X-9-105.
Results Reference
background

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Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder

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