The Correlation Between Blood omega3 and ADHD

Sponsor

Ayelet Omer Armon (Other)

Overall Status

Unknown status

CT.gov ID

NCT02391428

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder (ADHD)	Procedure: blood test Dietary Supplement: omega3 capsules	Early Phase 1

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

The Correlation Between Blood omega3 and ADHD

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Apr 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

blood omega3 [6 month]

Secondary Outcome Measures

ADHD Symptoms [6 month]
Will be assessed using the ADHD Rating Scale IV (ADHD RS).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ayelet Omer Armon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayelet Omer Armon, Dr., Ziv Hospital

ClinicalTrials.gov Identifier:

NCT02391428

Other Study ID Numbers:

ZIV-0019-14
Ziv

First Posted:

Mar 18, 2015

Last Update Posted:

Mar 19, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Ayelet Omer Armon, Dr., Ziv Hospital

ADHD

omega3

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Mar 19, 2015