Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2015-04-30
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)
NCT00874536
Supplementation of Phosphatidylserine (PS) and n-3 Long Chain Fatty Acids (EPA, DHA) in Children With ADHD
NCT00382616
Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD
NCT03542643
Intervention With Omega-3 in Children With Attention Deficit Hyperactivity Disorder(ADHD)
NCT02986672
Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
NCT00770627
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
blood test
Blood test: Small volume (3 ml) of blood will be taken by venipuncture into ethylenediaminetetraacetic acid (EDTA) tube.
omega3 capsules
Only ADHD children will be given a supply of omega3 capsules (containing 400 mg EPA and 200 mg DHA)
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.
blood test
Blood test: Small volume (3 ml) of blood will be taken by venipuncture into ethylenediaminetetraacetic acid (EDTA) tube.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
blood test
Blood test: Small volume (3 ml) of blood will be taken by venipuncture into ethylenediaminetetraacetic acid (EDTA) tube.
omega3 capsules
Only ADHD children will be given a supply of omega3 capsules (containing 400 mg EPA and 200 mg DHA)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
6 Years
14 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ayelet Omer Armon
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ayelet Omer Armon
Dr.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ziv
Identifier Type: OTHER
Identifier Source: secondary_id
ZIV-0019-14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.