The effect of short-term co-administration of folate on aggressive behaviors in Attention Deficit Hyperactivity Disorder (ADHD): a double blind randomized controlled trial
This randomized controlled clinical trial investigates the efficacy of folic acid as an adjuvant medication on aggressive behaviors in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Children with ADHD and aggressive behaviors are included. Parents report their children aggressive behaviors using the ADHD Rating Scale and Over Aggressive Behavior Scale. Serious medical condition and lack of providing written informed consent are exclusion criteria. Forty qualified patients will be divided into intervention and control group randomly. Intervention group receive folic acid (5mg/day) and control group receive placebo. The participants are assessed every 30 days for 2 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108193930N11
Registration date:2011-09-18, 1390/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-18, 1390/06/27
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-08-19, 1390/05/28
Expected recruitment end date
2012-08-19, 1391/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of short-term co-administration of folate on aggressive behaviors in Attention Deficit Hyperactivity Disorder (ADHD): a double blind randomized controlled trial
Public title
The effect of short-term co-administration of folate on aggressive behaviors in Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) according to DSM-IV diagnostic criteria; children and adolescents aged 7 to 19 years old. Exclusion criteria: Self reported an allergic reaction to folic acid; kidney disease; being on dialysis; infection; anemia; epilepsy; taking medications such as phenytoin, methotrexate, nitrofurantoin, tetracycline barbiturates such as Phenobarbital, primidone; lack of providing written informed consent for participation; a diagnosed psychotic disorder; extensive use of nutritional folic acid supplements within the previous 3 months; behavior therapy or any other psychotherapy in the last three months or during this study.
Age
From 7 years old to 19 years old
Gender
Both
Phase
2-3
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Postal code
Approval date
2011-07-12, 1390/04/21
Ethics committee reference number
CT-90-2711
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder (ADHD)
ICD-10 code
F 90
ICD-10 code description
Hyperkinetic disorders
Primary outcomes
1
Description
ADHD rating questionnaire
Timepoint
evey 30 days
Method of measurement
parent report
Secondary outcomes
1
Description
modified Overt Aggression Scale
Timepoint
evey 30 days
Method of measurement
parent report
Intervention groups
1
Description
folic acid (5mg/day)
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
Hafez Hospital, Chamran Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Hafez Hospital, Chamran Street
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)