The Correlation Between Blood omega3 and ADHD

March 18, 2015 updated by: Ayelet Omer Armon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children who diagnosed with ADHD
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.
Procedure: blood test
Blood test: Small volume (3 ml) of blood will be taken by venipuncture into ethylenediaminetetraacetic acid (EDTA) tube.
Dietary supplement: omega3 capsules
Only ADHD children will be given a supply of omega3 capsules (containing 400 mg EPA and 200 mg DHA)
Experimental: Control group of children without ADHD

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.
Procedure: blood test
Blood test: Small volume (3 ml) of blood will be taken by venipuncture into ethylenediaminetetraacetic acid (EDTA) tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood omega3
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADHD Symptoms
Time Frame: 6 month
Will be assessed using the ADHD Rating Scale IV (ADHD RS).
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayelet Omer Armon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIV-0019-14
  • Ziv (Other Identifier: medical center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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