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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
JGalduroz, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01807299
First received: March 7, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Dietary Supplement: Omega 3
Other: Physical Training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Improve the behavior and cognitive functions of ADHD children. [ Time Frame: The outcomes will be assessed after treatment (After three months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Training
The training group will make physical exercise for three months (three times a week).
Dietary Supplement: Omega 3
Sedentary
The sedentary group will be oriented not to make any type of physical training for three months.
Dietary Supplement: Omega 3
Placebo Comparator: Placebo
The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Other: Physical Training
Experimental: Omega 3
The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Other: Physical Training

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807299

Contacts
Contact: José Carlos F Galduróz, Md PhD 55 11 21490155 galduroz@unifesp.br

Locations
Brazil
Departamento de Psicobiologia Recruiting
São Paulo, Brazil, 04024002
Contact: José Carlos F Galduróz, Md PhD    55 11 21490155    galduroz@unifesp.br   
Principal Investigator: José Carlos F Galduróz, Md PhD         
Sub-Investigator: Viviane Grassmann, Md         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: José Carlos F Galduróz, Md PhD Universidade Federal de São Paulo (UNIFESP)
  More Information

No publications provided

Responsible Party: JGalduroz, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01807299     History of Changes
Other Study ID Numbers: ADHD_Omega_Exercise
Study First Received: March 7, 2013
Last Updated: March 7, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Physical Training
ADHD-Attention deficit hyperactivity disorder
Omega 3

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014