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The Correlation Between Blood omega3 and ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
blood test
omega3 capsules
Sponsored by
Ayelet Omer Armon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring ADHD, omega3

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- ADHD group: Children diagnosed with ADHD aged 6-14; children who have not received a dietary supplement of omega3 in the last month

Control group inclusion criteria: Children without ADHD and related neuropsychiatric syndromes aged 6-14, Children who have not received a dietary supplement of omega3 in the last month.

Exclusion Criteria:

- Children with severe chronic or autoimmune disorders, children who received a dietary supplement of omega3 in the last month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Children who diagnosed with ADHD

    Control group of children without ADHD

    Arm Description

    The ADHD children will be asked to consume omega3 capsules for 6 months. Blood will be taken for omega3 analysis in day 0, after 3 and 6 months.

    Blood test: The control group of 30 children (age and gender match) without ADHD and related neuropsychiatric syndromes, who were hospitalized due to surgical or orthopedic problems. Only when blood will be taken for clinical purposes, the investigators will ask the children and their parents to allow the collection of an additional small blood tube.

    Outcomes

    Primary Outcome Measures

    blood omega3

    Secondary Outcome Measures

    ADHD Symptoms
    Will be assessed using the ADHD Rating Scale IV (ADHD RS).

    Full Information

    First Posted
    March 5, 2015
    Last Updated
    March 18, 2015
    Sponsor
    Ayelet Omer Armon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02391428
    Brief Title
    The Correlation Between Blood omega3 and ADHD
    Official Title
    The Correlation Between Blood omega3 and ADHD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ayelet Omer Armon

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Attention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with important physiologically active functions. Aim: Study the relationship between omega3 blood values and ADHD clinical status. Methods: The investigators will recruit 30 children, who have been diagnosed with ADHD by a child psychiatrist. In addition the investigators will recruit a control group of 30 children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children. The ADHD children will be asked to consume omega3 capsules for 6 month. After 3 and 6 months, all children will undergo clinical examination and blood tests will be taken for omega3 index analysis. Blind frozen samples of isolated red blood cell (RBC) will be analyzed according to the omega3 index methodology.
    Detailed Description
    Attention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with important physiologically active functions. Aim: To investigate influence effects of omega3 dietary supplementation on ADHD symptoms and the measured blood values. Methods: The study will be authorized by the Ziv Helsinki Committee and the Ministry of Health. Written Informed consent will obtained from parents. The investigators will recruit 30 children, who have been diagnosed with ADHD by a child psychiatrist. In addition the investigators will recruit a control group of 30 children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Hyperactivity Disorder (ADHD)
    Keywords
    ADHD, omega3

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Children who diagnosed with ADHD
    Arm Type
    Experimental
    Arm Description
    The ADHD children will be asked to consume omega3 capsules for 6 months. Blood will be taken for omega3 analysis in day 0, after 3 and 6 months.
    Arm Title
    Control group of children without ADHD
    Arm Type
    Experimental
    Arm Description
    Blood test: The control group of 30 children (age and gender match) without ADHD and related neuropsychiatric syndromes, who were hospitalized due to surgical or orthopedic problems. Only when blood will be taken for clinical purposes, the investigators will ask the children and their parents to allow the collection of an additional small blood tube.
    Intervention Type
    Procedure
    Intervention Name(s)
    blood test
    Intervention Description
    Blood test: Small volume (3 ml) of blood will be taken by venipuncture into ethylenediaminetetraacetic acid (EDTA) tube.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    omega3 capsules
    Intervention Description
    Only ADHD children will be given a supply of omega3 capsules (containing 400 mg EPA and 200 mg DHA)
    Primary Outcome Measure Information:
    Title
    blood omega3
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    ADHD Symptoms
    Description
    Will be assessed using the ADHD Rating Scale IV (ADHD RS).
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - ADHD group: Children diagnosed with ADHD aged 6-14; children who have not received a dietary supplement of omega3 in the last month Control group inclusion criteria: Children without ADHD and related neuropsychiatric syndromes aged 6-14, Children who have not received a dietary supplement of omega3 in the last month. Exclusion Criteria: - Children with severe chronic or autoimmune disorders, children who received a dietary supplement of omega3 in the last month

    12. IPD Sharing Statement

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    The Correlation Between Blood omega3 and ADHD

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