ADHDPhase 2ADHD-3NCT00700323
PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children
A Phase 2 study testing PS-Omega3 conjugate supplementation in people with ADHD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- PS-Omega3 conjugate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Jul 2009
- Phase
- Phase 2
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental written informed consent.
- Age: 13≥ years ≥8 (including).
- Gender: both male and female.
- TOVA computerized test score ≤-1.8 at baseline.
- Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
- Normal weight and height according to Israeli standards.
- 21 days without any treatment for ADHD symptoms, whether medication or food supplement.
Who cannot join
- History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
- Pervasive developmental disorder or Non-Verbal Learning Disability
- Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
- History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
- Having a sibling already included in the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel-Aviv Sourasky Medical Center
Tel Aviv
Nachum Vaisman, Prof', 972-3-697-4807, vaisman@tasmc.health.gov.il
Nachum Vaisman, Prof'
About this study
Official title: Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.
- Conditions
- ADHD
- Being tested
- PS-Omega3 conjugate supplementation, placebo
- Keywords
- ADHD, ADHD diagnosed children
- 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.
PS-Omega3 conjugate supplementationDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients receiving active product Receives: Dietary Supplement: PS-Omega3 conjugate supplementation |
| 2 | Placebo comparator | Patients receiving placebo Receives: Dietary Supplement: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Enzymotec
- Investigators
- Nachum Vaisman, Prof', Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700323
- Sponsor's protocol ID
- TASMC-08-NV-263
- Other IDs
- 263-08-TLV
- Acronym
- ADHD-3
- Status last verified
- Jun 2008
- First submitted
- 17 Jun 2008
- Last updated
- 18 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children
- ClinicalTrials.gov ID
- NCT00700323
- Acronym / sponsor ID
- ADHD-3 / TASMC-08-NV-263
- Conditions
- ADHD
- Keywords
- ADHD, ADHD diagnosed children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Enzymotec
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 18 Jun 2008 (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.
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: PS-Omega3 conjugate supplementationPatients receiving active product |
| 2 | Placebo comparator | Dietary Supplement: placeboPatients receiving placebo |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parental written informed consent.
- Age: 13≥ years ≥8 (including).
- Gender: both male and female.
- TOVA computerized test score ≤-1.8 at baseline.
- Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
Key exclusion criteria (5 listed)
- History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
- Pervasive developmental disorder or Non-Verbal Learning Disability
- Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
- History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
- Having a sibling already included in the study.
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 |
|---|---|---|
| PS-Omega3 conjugate supplementation | Dietary supplement | 1 |
| placebo | Dietary supplement | 2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2008.
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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.
Nachum Vaisman, Prof' principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PS-Omega3 conjugate supplementation in people with ADHD, run by Tel-Aviv Sourasky Medical Center 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 7 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: status not confirmed, as of the sponsor's last update on 18 Jun 2008. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof' (972-3-697-4807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 18 Jun 2008.