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Clinical Trials/NCT02391428
NCT02391428
Unknown
Early Phase 1

The Correlation Between Blood omega3 and ADHD

Ayelet Omer Armon0 sites60 target enrollmentApril 2015

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor
Ayelet Omer Armon
Enrollment
60
Primary Endpoint
blood omega3
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
April 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ayelet Omer Armon
Responsible Party
Sponsor Investigator
Principal Investigator

Ayelet Omer Armon

Dr.

Ziv Hospital

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

Outcomes

Primary Outcomes

blood omega3

Time Frame: 6 month

Secondary Outcomes

  • ADHD Symptoms(6 month)

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