The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children
AOE
1 other identifier
interventional
68
1 country
1
Brief Summary
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 8, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
February 28, 2020
CompletedFebruary 28, 2020
February 1, 2020
1.8 years
March 7, 2013
February 13, 2019
February 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Conners Scale
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.
3 months
Study Arms (4)
Physical Training
EXPERIMENTALThe training group will make physical exercise for three months (three times a week).
Sedentary
OTHERThe sedentary group will be oriented not to make any type of physical training for three months.
Placebo
PLACEBO COMPARATORThe omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Omega 3
EXPERIMENTALThe omega 3 group will receive 2g per day of fish oil during 90 days treatment
Interventions
Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
Eligibility Criteria
You may qualify if:
- Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.
You may not qualify if:
- Taking psychoactive medications, taking omega supplement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departamento de Psicobiologia
São Paulo, 04024002, Brazil
Related Publications (1)
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.
PMID: 37058600DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- PhD José Carlos F. Galduróz
- Organization
- Universidade Federal de São Paulo
Study Officials
- PRINCIPAL INVESTIGATOR
José Carlos F Galduróz, Md PhD
Universidade Federal de São Paulo (UNIFESP)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2013
First Posted
March 8, 2013
Study Start
May 1, 2011
Primary Completion
March 1, 2013
Study Completion
May 1, 2015
Last Updated
February 28, 2020
Results First Posted
February 28, 2020
Record last verified: 2020-02