AntisocialPhase 2/3NCT02016079
Effect of Omega-3 Supplementation on Child Behavior Problems
A Phase 2/3 study testing omega-3 in people with Antisocial and Aggressive, run by Joint Child Health Project, Mauritius at 1 site in Mauritius.
Trial summary
The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Antisocial, Aggressive, Externalizing Behavior Problems
- What is being tested?
- omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteMauritius
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 2/3
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child
- age between 8 and 16 years
- residing in the community
Who cannot join
- fish allergy
- diagnosed mental disorder
- mental retardation
- on medication that may modify lipid metabolism
- extensive use of nutritional supplements within the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Omega-3 on Child Behavior Problems
The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.
Read the detailed description
This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. All behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior.
- Being tested
- omega-3
- Keywords
- randomized controlled trial, omega-3, nutrition, behavior problems, externalizing, internalizing, antisocial, aggressive
- Medical subject headings
- Antisocial Personality Disorder, Aggression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3Dietary supplement
Also called Smartfish
200 ml fruit drink containing omega-3
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | a fruit drink containing omega-3 Receives: Dietary Supplement: omega-3 |
| Fruit drink | Placebo comparator | the same fruit drink given in the experimental arm, but not containing omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behavior Checklist
The outcome measure assessed internalizing and externalizing behavior problems in children
Measured: 6 months
Reactive-Proactive Aggression Questionnaire
A self-report measure of reactive and proactive forms of aggressive behavior
Measured: 6 months
Antisocial Personality Screening Device
A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism
Measured: 6 months
Secondary outcomes (1)
WISC
estimate of IQ
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 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 AntisocialStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Child Health Project, Mauritius
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tashneem Moohamed, Joint Child Health Project, Mauritius
- Investigators
- Tashneem Moohamed, BSc, Principal investigator, Joint Child Health ProjectCyril Dalais, MSc, Principal investigator, Action Research Program, Educational Priroity Areas, Mauritius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016079
- Sponsor's protocol ID
- JCHP-01
- Other IDs
- JCHP-N3
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22.
PubMed 25146492
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Omega-3 on Child Behavior Problems
- ClinicalTrials.gov ID
- NCT02016079
- Acronym / sponsor ID
- JCHP-01
- Keywords
- randomized controlled trial, omega-3, nutrition, behavior problems, externalizing, internalizing, antisocial, aggressive
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Joint Child Health Project, MauritiusUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Dec 2013 (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.
The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.
Detailed description
This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. All behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior.
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 |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: omega-3a fruit drink containing omega-3 |
| Fruit drink | Placebo comparator | –the same fruit drink given in the experimental arm, but not containing omega-3 |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child
- age between 8 and 16 years
- residing in the community
Key exclusion criteria (5 listed)
- fish allergy
- diagnosed mental disorder
- mental retardation
- on medication that may modify lipid metabolism
- extensive use of nutritional supplements within the previous 3 months
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-3Also: Smartfish200 ml fruit drink containing omega-3 | Dietary supplement | Omega-3 |
Primary outcome
Child Behavior Checklist
Time frame: 6 months
The outcome measure assessed internalizing and externalizing behavior problems in children
Reactive-Proactive Aggression Questionnaire
Time frame: 6 months
A self-report measure of reactive and proactive forms of aggressive behavior
Antisocial Personality Screening Device
Time frame: 6 months
A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism
1 secondary outcome
WISC
Time frame: 6 months
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 19 Dec 2013.
- Derived from this study: PubMed 25146492Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22.
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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.
Tashneem Moohamed, BSc principal investigator
Joint Child Health Project
Cyril Dalais, MSc principal investigator
Action Research Program, Educational Priroity Areas, Mauritius
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing omega-3 in people with Antisocial and Aggressive, run by Joint Child Health Project, Mauritius at 1 site in Mauritius.
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 3 inclusion and 5 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 19 Dec 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 Mauritius. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Child Behavior Checklist (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT02016079, 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 19 Dec 2013.