Back to resultsSupplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
ADHD
Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Eye Q
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, PUFA
Eligibility Criteria
Inclusion Criteria:
- Patients will be boys between the ages of 8-16 years.
- Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD confirmed by Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
- Patients must be of normal intelligence as assessed by the Wechsler Intelligence Scale for Children - Revised Edition (WISC-R).
- Treatment of ADHD by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with ADHD without pharmacological treatment
Exclusion Criteria:
- Patients who have a documented history of Bipolar I or II disorder, psychosis or autism.
- Patients with a history of epilepsy
- Patients with a history of asthma treated with corticosteroids.
- Patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism.
- Patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study.
- Patients with a history of alcohol or drug abuse within the past 3 months (excessive or compulsive use as judged by the investigator).
Sites / Locations
- Child and Adolescent Psychiatry Department, Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Polyunsaturated fatty acids
placebo
Arm Description
6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg EPA, 174 mg DHA, 60 mg GLA per day)
6 capsules of olive oil per day divided in two daily doses.
Outcomes
Primary Outcome Measures
assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention
Secondary Outcome Measures
assessment of adverse events.
Full Information
NCT ID
NCT02114632
First Posted
March 23, 2014
Last Updated
April 13, 2014
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT02114632
Brief Title
Supplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Official Title
A Double Blind, Placebo Controlled Trial of Effectiveness of Omega-3 and Omega-6 Polyunsaturated Fatty Acids in Treatment of Children With Attention Deficit/Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy boys.
Detailed Description
The study is designed as a randomized, double-blind placebo-controlled trial with a total duration of 6 months. 100-120 boys with ADHD aged 8-16 years and 30 healthy boys will will be randomized to 3 months of treatment with a fixed dose of 6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg eicosapentaenoic acid (EPA), 174 mg docosahexaenoic acid (DHA), 60 mg gamma-linolenic acid (GLA) per day) or to placebo (olive oil). At 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive active treatment for the remaining 3 month period. Control group will receive active treatment for 6 month. The assessment of children will be made 3 times: at the point of start, after 3 months, and after 6 months. The assessments will be made using standardized interviews and questionnaires, neuropsychological tests, pediatric and neurological examination and taking a 5 ml sample of blood to assess level of polyunsaturated fatty acids (PUFA) in serum and in cell membranes of erythrocytes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, PUFA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyunsaturated fatty acids
Arm Type
Active Comparator
Arm Description
6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg EPA, 174 mg DHA, 60 mg GLA per day)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
6 capsules of olive oil per day divided in two daily doses.
Intervention Type
Dietary Supplement
Intervention Name(s)
Eye Q
Intervention Description
3 months of treatment with a polyunsaturated fatty acids or placebo. At 3 months a one-way treatment crossover of the placebo-group to active treatment was made so that both patient groups received active treatment for the remaining 3 month period.
Primary Outcome Measure Information:
Title
assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention
Time Frame
change from baseline at 6 months
Secondary Outcome Measure Information:
Title
assessment of adverse events.
Time Frame
change from baseline at 6 months
Other Pre-specified Outcome Measures:
Title
assessment of connection between level of fatty acids in serum and intensity of ADHD symptoms in treated group according to placebo intervention
Time Frame
change from baseline at 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will be boys between the ages of 8-16 years.
Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD confirmed by Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
Patients must be of normal intelligence as assessed by the Wechsler Intelligence Scale for Children - Revised Edition (WISC-R).
Treatment of ADHD by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with ADHD without pharmacological treatment
Exclusion Criteria:
Patients who have a documented history of Bipolar I or II disorder, psychosis or autism.
Patients with a history of epilepsy
Patients with a history of asthma treated with corticosteroids.
Patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism.
Patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study.
Patients with a history of alcohol or drug abuse within the past 3 months (excessive or compulsive use as judged by the investigator).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Grygo, MD
Organizational Affiliation
Medical University of Warsaw, Child and Adolescent Psychiatry Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatry Department, Medical University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-576
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Supplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
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