This study is designed to evaluating and comparing the therapeutic effects of two drugs Omega-3 and Methylphenidate (Ritalin) in treating patients with attention deficit hyperactivity disorder. This study is a Clinical trial study and is a Parallel method that is performed on 85 cases of children aged six to twelve screening in Yazd city. So that 29 people were treated with Methylphenidate (Ritalin), 28 people were treated with omega-3 and others 28 people were in the placebo group. Children with Score > 65 on both parents and teachers version of conners rating scale , IQ > 70 using Kaufman brief intelligence test and Informed consent were included while children with occurrence of unintended side effect, who had previous treatment of ADHD and also who had taken omega 3 supplenet during past 3 months and severe psychiatric disorders were excluded from study.The tool used in this study was Conners standardized questionnaire. The scores that obtained from these questionnaires were analyzed with using Chi-square test and Paired-T-test in the software environment PASW 18.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304035393N3
Registration date:2013-07-03, 1392/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-03, 1392/04/12
Registrant information
Name
Hamid Reza Soltani.G
Name of organization / entity
Yazd Islamic Azad University, Medical Society of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 35 1623 1817
Email address
hrsgmed@yahoo.com
Recruitment status
Recruitment complete
Funding source
Islamic Azad University branch Yazd
Expected recruitment start date
2009-06-21, 1388/03/31
Expected recruitment end date
2011-04-24, 1390/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of Omega-3 and methylphenidate(Ritalin) in treating patients with Attention Deficit Hyperactivity Disorder
Public title
Omega-3 effects on Patient with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: Children with Score > 65 on both parents and teachers version of Conners rating scale; IQ > 70 using Kaufman brief intelligence test; Informed consent) (Exclusion Criteria:occurrence of unintended side effects;previous treatment of ADHD; omega 3 supplement consumption during past 3 months;severe psychiatric disorders )
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Ali ben Abitaleb medical school,
Street address
Ali Ben Abitaleb Medical school, Islamic Azad University branch Yazd, Yazd, Iran
City
Yazd
Postal code
Approval date
2010-07-03, 1389/04/12
Ethics committee reference number
44215
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Connors standard test for ADHD patients
Timepoint
4 weeks
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
(Control: Methylphenidate(Ritalin), 0.3-1 mg/kg three times a day )
(Intervention: Therapeutic doses of Omega-3 (1 gr), 3 capsules divided in three days with Methylphenidate(Ritalin), 0.3-1 mg/kg three times a day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Kargar Hospital
Full name of responsible person
Hoda Hekmat
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Yazd
Full name of responsible person
Nasrollah Bashardoost
Street address
Ali ben Abitaleb medical school, Safaeiyeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd Branch, Islamic Azad university
Full name of responsible person
Hamid Reza Soltani
Position
General practitioner
Other areas of specialty/work
Street address
Ali Ben Abitaleb Medical school, Safaeiyeh
City
Yazd
Postal code
Phone
+98 35 1821 0540
Fax
Email
hrsgmed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Branch, Islamic Azad University
Full name of responsible person
Naser Dashti
Position
Assistant professor of Psychiatry
Other areas of specialty/work
Street address
Shohadaye Kargar Hospital
City
Yazd
Postal code
Phone
+98 35 1811 2000
Fax
Email
Dr_naserdashti@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Branch, Islamic Azad University
Full name of responsible person
Hamid Reza Soltani
Position
General Practitioner
Other areas of specialty/work
Street address
Ali Ben Abitaleb Medical school,
City
Yazd
Postal code
Phone
+98 35 1821 0540
Fax
Email
hrsgmed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)