This non-randomized 8-week controlled clinical trial examines the effect of vitamin D for treating children with autism and vitamin serum level less than 25ng/ml. There are two groups. Each group incudes 15 patients. One group will receive vitamin D. The other group will receive vitamin D plus risperidone. Aberrant Behavior checklist is used to measure the clinical symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405273930N34
Registration date:2014-10-17, 1393/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-17, 1393/07/25
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 Sceicnes
Expected recruitment start date
2014-08-07, 1393/05/16
Expected recruitment end date
2015-08-07, 1394/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Vitamin D for treating autism, a controlled clinical trial
Public title
Vitamin D for treating autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Autism according to DSM-IV diagnostic criteria; aged 3 to 18 years old; and serum level of vitamin D less than 25 ng/mL.
Exclusion Criteria: primary diagnosis of a psychotic disorder; active substance abuse or dependence; history of allergy to vitamin D; and unstable medical condition.
Age
From 3 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciecnes
Street address
Shiraz University of Medical Sceinces
City
shiraz
Postal code
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
92-01-34-6787
Health conditions studied
1
Description of health condition studied
autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Clinical behavioral symptoms
Timepoint
Every 4 weeks
Method of measurement
Abbrant Behavior Checklist
Secondary outcomes
empty
Intervention groups
1
Description
An intramuscular vitamin D 300,000 IU repeated one week later plus risperidone (0.5 to 3 mg/day)
Category
Treatment - Drugs
2
Description
control group will receive vitamin D
Category
Treatment - Drugs
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
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
Basi Hasemi
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
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Meysam Hosini
Position
Medical student
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
mey30_ben@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
ghanizadeha@hotmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)