An Early Phase 1 interventional study of blood test and omega3 capsules in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Ayelet Omer Armon. Status unknown. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-19.
Sponsored by Ayelet Omer Armon · Early Phase 1, Interventional, and Supportive care
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.
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.
1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.
This study's planned enrollment of 60 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
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- 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
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
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.
Only ADHD children will be given a supply of omega3 capsules (containing 400 mg EPA and 200 mg DHA)
blood omega3
Time frame: 6 month
ADHD Symptoms
Will be assessed using the ADHD Rating Scale IV (ADHD RS).
Time frame: 6 month
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
Attention Deficit Disorder with Hyperactivity →