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Completed

NCT Number: NCT01807299

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

The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.

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Key information

Age range

7 year–14 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Psicobiologia

São Paulo, 04024002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega 3

Dietary Supplement

Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.

Physical training

Other

Primary outcomes

  1. Conners Scale

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit

Acronym: AOE

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Mar 8, 2013
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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