Attention Deficit Hyperactivity DisorderNCT00874536
Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)
A study testing omega-3 fatty acid alpha-linolenic acid (ALA) in people with Attention Deficit Hyperactivity Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty acids have been used in this setting, yet results are conflicting. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- omega-3 fatty acid alpha-linolenic acid (ALA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis
- informed consent
Who cannot join
- refusal of any testing
- any comorbidities
- any medication or supplement use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD
It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end assessments will include ADHD-related questionnaires and a computerized test. The investigators hypothesize that ALA supplementation will prove beneficial for children with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- omega-3 fatty acid alpha-linolenic acid (ALA), Placebo
- Keywords
- ADHD, methylphenidate, omega-3
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acid alpha-linolenic acid (ALA)Dietary supplement
3 grams of ALA-containing plant oil
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ALA | Experimental | This group will receive the ALA supplement Receives: Dietary Supplement: omega-3 fatty acid alpha-linolenic acid (ALA) |
| Placebo | Placebo comparator | This group will receive the placebo supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms
scores of DSM and Conners questionnaires
Measured: 8 weeks
Secondary outcomes (1)
Computerized test performance
performance in a computerized test of attention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Association of Pediatricians
- Responsible party
- Principal investigator, gal dubnov raz, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874536
- Sponsor's protocol ID
- GDR3-HMO-CTIL
- Status last verified
- Jul 2013
- First submitted
- 1 Apr 2009
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
PubMed 37058600
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD
- ClinicalTrials.gov ID
- NCT00874536
- Acronym / sponsor ID
- GDR3-HMO-CTIL
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, methylphenidate, omega-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Israel Association of Pediatricians
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end assessments will include ADHD-related questionnaires and a computerized test. The investigators hypothesize that ALA supplementation will prove beneficial for children with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA | Experimental | Dietary Supplement: omega-3 fatty acid alpha-linolenic acid (ALA)This group will receive the ALA supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group will receive the placebo supplement |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ADHD diagnosis
- informed consent
Key exclusion criteria (3 listed)
- refusal of any testing
- any comorbidities
- any medication or supplement use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 fatty acid alpha-linolenic acid (ALA)3 grams of ALA-containing plant oil | Dietary supplement | ALA |
| Placebo | Dietary supplement | Placebo |
Primary outcome
ADHD symptoms
Time frame: 8 weeks
scores of DSM and Conners questionnaires
1 secondary outcome
Computerized test performance
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Derived from this study: PubMed 37058600Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acid alpha-linolenic acid (ALA) in people with Attention Deficit Hyperactivity Disorder, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD symptoms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00874536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.