The Correlation Between Blood omega3 and ADHD

Transcription

1 The Correlation Between Blood omega3 and ADHD This study is not yet open for participant recruitment. (see Contacts and Locations) Verified March 2015 by Ziv Hospital Sponsor: Ayelet Omer Armon Information provided by (Responsible Party): Ayelet Omer Armon, Ziv Hospital ClinicalTrials.gov Identifier: NCT First received: March 5, 2015 Last updated: March 11, 2015 Last verified: March 2015 History of Changes Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record Purpose 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 toadhd. 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 Intervention Phase

2 Attention Deficit Hyperactivity Disorder (ADHD) Procedure: blood test Dietary Supplement: omega3 capsules Phase 0 Study Type: Interventional Study Design: Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care Official Title: The Correlation Between Blood omega3 and ADHD Resource links provided by NLM: Drug Information available for: Omega-3 Fatty Acids U.S. FDA Resources Further study details as provided by Ziv Hospital: Primary Outcome Measures: blood omega3 [ Time Frame: 6 month ] [ Designated as safety issue: No ] Secondary Outcome Measures: ADHD Symptoms [ Time Frame: 6 month ] [ Designated as safety issue: No ] Will be assessed using the ADHD Rating Scale IV (ADHD RS). Estimated Enrollment: 60 Study Start Date: April 2015 Estimated Study Completion Date: April 2016

3 Estimated Primary Completion Date: measure) September 2015 (Final data collection date for primary outcome Arms Assigned Interventions 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, we 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. 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. We will recruit 30 children, who have been diagnosed with ADHD by a child psychiatrist. In addition we will recruit a control group of 30 children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children. Eligibility Ages Eligible for Study: 6 Years to 14 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Criteria

4 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 Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. No Contacts or Locations Provided More Information No publications provided Responsible Party: Ayelet Omer Armon, Dr., Ziv Hospital ClinicalTrials.gov Identifier: NCT History of Changes Other Study ID Numbers: ZIV , Ziv Study First Received: March 5, 2015 Last Updated: March 11, 2015 Health Authority: Israel: Ministry of Health Keywords provided by Ziv Hospital: ADHD omega3 Additional relevant MeSH terms:

5 Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Mental Disorders Diagnosed in Childhood ClinicalTrials.gov processed this record on March 17, 2015