Objective: Considering the current controversies regarding the efficacy 0f PUFA in the treatment of children with ADHD, the present study is designed to evaluate the impact of these nutrients in this disorder. Methods and materials: 40 children, 6-12 years old with ADHD were randomly assigned in 2 groups. The first one received methylphenidate plus PUFA (241 mg DHA, 33mg EPA and 180 mg omega6) and the second one received methylphenidate with placebo. The patients were evaluated at the baseline and on weeks: 2, 4, 6, 8 and 10 by ADHD-Rating Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803122000N1
Registration date:2011-05-21, 1390/02/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-21, 1390/02/31
Registrant information
Name
Rozita Davari Ashtiani
Name of organization / entity
Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 1023
Email address
rodavari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2009-09-01, 1388/06/10
Expected recruitment end date
2010-03-30, 1389/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Poly Unsaturated Fatty Acid as a combination treatment in children with Attention Deficit Hyperactivity Disorder
Public title
Omega-3 in the treatment of Attention Deficit Hyperactivity Disoder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- children with 6-12 years of age, 2- ADHD diagnosis based on DSM-IV-TR, 3- Score of at least 20 in ADHD-RS (parent form). Exclusion criteria:
1- Any major comorbid psychiatric disorder except ODD and LD based on K-SADS, 2- IQ below 70, 3- Use of any psychotropic drug or substance in at least 2 weeks before the study, 4- any major neurological disease, 5- use of PUFA included substances or nutrients more than once a week
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:
40
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
Behavioral sciences Research Center, Shahid Beheshti University of Medical sciences
Street address
Imam Hossein Hospital, Shahid Madani Street
City
Tehran
Postal code
1617763141
Approval date
2009-10-25, 1388/08/03
Ethics committee reference number
6309
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
ADHD severity
Timepoint
every 2 weeks
Method of measurement
ADHD-Rating Scale
Secondary outcomes
1
Description
drug adverse effects
Timepoint
every 2 weeks
Method of measurement
adverse effects questionnair of methylphenidate and PUFA
Intervention groups
1
Description
Intervention group: methylphenidate 0.3-1 mg/kg/day+ PUFA 430 mg/day,for 10 weeks, dose adjustment based on therapeutic response and side effects
Category
Treatment - Drugs
2
Description
Control group: Metylphenidate 0.3-1 mg/kg/day + placebo (producted by the same company which produced PUFA), for 10 weeks, dose adjustment based on therapeutic response and side effects
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Rozita Davari-Ashtiani
Street address
Shahid Madani Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zahiroddin
Street address
Imam Hossein hospital, Shahid Madani street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rozita Davari-Ashtiani
Position
associate professor
Other areas of specialty/work
Street address
Imam hossein hospital, Shahid Madani street
City
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Fax
+98 21 7755 1023
Email
rodavari@sbmu.ac.ir , rodavari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical sciences
Full name of responsible person
Rozita Davari-Ashtiani
Position
Associate professor
Other areas of specialty/work
Street address
Imam hossein Hospital, shahid Madani Street
City
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Fax
+98 21 7755 1023
Email
rodavari@sbmu.ac.ir , rodavari2yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical sciences
Full name of responsible person
Rozita Davari-Ashtiani
Position
associate professor
Other areas of specialty/work
Street address
Imam Hossein hospital, shahid Madani Street
City
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Fax
+98 21 7755 1023
Email
rodavari@sbmu.ac.ir , rodavari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)