The Correlation Between Blood omega3 and ADHD

NCT02391428 | Unknown Early Phase 1

• 2 other identifiers: ZIV-0019-14Ziv
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD; omega3

Outcome Measures

Primary Outcomes (1)

• blood omega3

  6 month

Secondary Outcomes (1)

• ADHD Symptoms

  6 month

Study Arms (2)

Children who diagnosed with ADHD

EXPERIMENTAL

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; Dietary Supplement: omega3 capsules

Control group of children without ADHD

EXPERIMENTAL

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

Interventions

blood test PROCEDURE

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

Children who diagnosed with ADHD; Control group of children without ADHD

omega3 capsules DIETARY_SUPPLEMENT

Only ADHD children will be given a supply of omega3 capsules (containing 400 mg EPA and 200 mg DHA)

Children who diagnosed with ADHD

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ayelet Omer Armon: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Hematologic Tests; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 18, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: March 19, 2015

Record last verified: 2015-03