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The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children (AOE)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Omega 3
Physical Training
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Physical Training, ADHD-Attention deficit hyperactivity disorder, Omega 3

Eligibility Criteria

7 Years - 14 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.

Exclusion Criteria:

  • Taking psychoactive medications, taking omega supplement.

Sites / Locations

  • Departamento de Psicobiologia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Placebo Comparator

Experimental

Arm Label

Physical Training

Sedentary

Placebo

Omega 3

Arm Description

The training group will make physical exercise for three months (three times a week).

The sedentary group will be oriented not to make any type of physical training for three months.

The omega 3 group will receive 2g per day of mineral oil during 90 days treatment

The omega 3 group will receive 2g per day of fish oil during 90 days treatment

Outcomes

Primary Outcome Measures

Conners Scale
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2013
Last Updated
February 17, 2020
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01807299
Brief Title
The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children
Acronym
AOE
Official Title
The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Physical Training, ADHD-Attention deficit hyperactivity disorder, Omega 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Training
Arm Type
Experimental
Arm Description
The training group will make physical exercise for three months (three times a week).
Arm Title
Sedentary
Arm Type
Other
Arm Description
The sedentary group will be oriented not to make any type of physical training for three months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Arm Title
Omega 3
Arm Type
Experimental
Arm Description
The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3
Intervention Description
Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
Intervention Type
Other
Intervention Name(s)
Physical Training
Primary Outcome Measure Information:
Title
Conners Scale
Description
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school. Exclusion Criteria: Taking psychoactive medications, taking omega supplement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Carlos F Galduróz, Md PhD
Organizational Affiliation
Universidade Federal de São Paulo (UNIFESP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Psicobiologia
City
São Paulo
ZIP/Postal Code
04024002
Country
Brazil

12. IPD Sharing Statement

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The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children

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