Attention Deficit Hyperactivity DisorderAOENCT01807299
The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children
A study testing Omega 3 and Physical Training in people with Attention Deficit Hyperactivity Disorder, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life. Read more about this study
- Who is it for?
- Ages 7 to 14 years, men only
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Omega 3 and Physical Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.
Who cannot join
- Taking psychoactive medications, taking omega supplement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.
Read the detailed description
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life. The treatment of this disease is expensive and difficult. Moreover, physical exercise and omegas consumption may improve the cognitive functions and behavior, so it could be an interesting strategy to improve this disorder. The aim of the present study is to verify the effects of multiple components physical training and the consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be selected. The volunteers will be randomly divided into four groups: Physical Training Group (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The protocol of the experiment will last three months in which the OPTG will make physical training and receive fish oil capsules, and the PTG will make only the physical training and receive a placebo of fish oil. The others groups will be oriented not to make any type of physical training, but the OG will receive fish oil capsule, and the CG will receive a placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will be made at the beginning and at the end of the protocol.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Omega 3, Physical Training
- Keywords
- Physical Training, ADHD-Attention deficit hyperactivity disorder, 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 3Dietary supplement
Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
Physical TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Physical Training | Experimental | The training group will make physical exercise for three months (three times a week). Receives: Dietary Supplement: Omega 3 |
| Sedentary | Other | The sedentary group will be oriented not to make any type of physical training for three months. Receives: Dietary Supplement: Omega 3 |
| Placebo | Placebo comparator | The omega 3 group will receive 2g per day of mineral oil during 90 days treatment Receives: Other: Physical Training |
| Omega 3 | Experimental | The omega 3 group will receive 2g per day of fish oil during 90 days treatment Receives: Other: Physical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners Scale
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos Fernandes Galduroz MD, Federal University of São Paulo
- Investigators
- José Carlos F Galduróz, Md PhD, Principal investigator, Universidade Federal de São Paulo (UNIFESP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807299
- Sponsor's protocol ID
- ADHD_Omega_Exercise
- Acronym
- AOE
- Status last verified
- Feb 2020
- First submitted
- 7 Mar 2013
- Last updated
- 28 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit
- ClinicalTrials.gov ID
- NCT01807299
- Acronym / sponsor ID
- AOE / ADHD_Omega_Exercise
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Physical Training, ADHD-Attention deficit hyperactivity disorder, Omega 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 28 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.
Detailed description
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life. The treatment of this disease is expensive and difficult. Moreover, physical exercise and omegas consumption may improve the cognitive functions and behavior, so it could be an interesting strategy to improve this disorder. The aim of the present study is to verify the effects of multiple components physical training and the consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be selected. The volunteers will be randomly divided into four groups: Physical Training Group (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The protocol of the experiment will last three months in which the OPTG will make physical training and receive fish oil capsules, and the PTG will make only the physical training and receive a placebo of fish oil. The others groups will be oriented not to make any type of physical training, but the OG will receive fish oil capsule, and the CG will receive a placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will be made at the beginning and at the end of the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical Training | Experimental | Dietary Supplement: Omega 3The training group will make physical exercise for three months (three times a week). |
| Sedentary | Other | Dietary Supplement: Omega 3The sedentary group will be oriented not to make any type of physical training for three months. |
| Placebo | Placebo comparator | Other: Physical TrainingThe omega 3 group will receive 2g per day of mineral oil during 90 days treatment |
| Omega 3 | Experimental | Other: Physical TrainingThe omega 3 group will receive 2g per day of fish oil during 90 days treatment |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.
Key exclusion criteria (1 listed)
- Taking psychoactive medications, taking omega supplement.
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 3Capsules of omega 3, 1000mg / capsules. Administered 3 times a day. | Dietary supplement | Physical Training, Sedentary |
| Physical Training | Other | Omega 3, Placebo |
Primary outcome
Conners Scale
Time frame: 3 months
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
José Carlos F Galduróz, Md PhD principal investigator
Universidade Federal de São Paulo (UNIFESP)
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 and Physical Training in people with Attention Deficit Hyperactivity Disorder, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 28 Feb 2020. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Conners Scale (time frame: 3 months). 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 NCT01807299, 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 28 Feb 2020.