In this randomized clinical trial 70 patients with schizophrenia according to DSM-V criteria was divided randomly in two groups. In first group as a intervention group 35 patients received 20-25 mg olanzapine for 3 Months and 300000 IU Vitamin D as IM Injection Form for 1 Time. and other group with the same fallow up received 20-25 mg olanzapine and placebo .in each group FBS,cratinin ,ca,pr ,parathormon hormone and Positive and Negative Syndrome Scale (PANSS )Criteria at the first and the 1,2,3 Months was measured and com paired.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507087373N5
Registration date:2017-05-14, 1396/02/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-14, 1396/02/24
Registrant information
Name
Hamidreza Jamilian
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 5758
Email address
jamilian.hr@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Vitamin D supplementation in the treatment of schizophrenia
Public title
The efficacy of Vitamin D supplementation in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of schizophrenia according to DSM-5 criteria ,age range 18-68 ,a score of at least 60 in PANSS
Exclusion criteria:Mental Retardation; Organic brain disease; Parathyroid disorders; Use of Vitamin D Supplementation in recent 3 months; Pregnancy and Lactation; Vitamin D metabolism disorders; serum level of Vitamin D below 10 nmol/ml; serum level of Vitamin D over 100 nmol/ml; No interest to continue treatment; substance abuse; GFR below 60 ml/min; No response to previous treatment with Olanzapin; BMI over 30
Age
From 18 years old to 68 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
70
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 Arak University of Medical Sciences
Street address
Basij Square
City
ARAK
Postal code
Approval date
2015-06-29, 1394/04/08
Ethics committee reference number
IR.ARAKMU.REC.1394.93
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive and Negative Syndrome Scale(PANSS)
Timepoint
Before intervention and every one month for 3 months
Method of measurement
Clinical Examination
Secondary outcomes
1
Description
extrapyramidal side effects
Timepoint
before intervention and every one month for 3 months
Method of measurement
clinical exam
Intervention groups
1
Description
Intervention group: receive olanzapin 10-25 mg/d for 3 months with vitamin D 300000 IU IM at the begining of intervention.
Category
Treatment - Drugs
2
Description
control group: receive olanzapine 10-25 mg/d for 3 months with placebo at the beginning of intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
amir kabir hospital and emam reza clinic
Full name of responsible person
hamidreza jamilian
Street address
amir kabir hospital and emam reza clinic
City
arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancer for research , Arak University of Medical Sciences
Full name of responsible person
Dr.yaghoobi
Street address
Basij Square
City
ARAK
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancer for research , Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Jamilian
Position
Board of Psychiatry,Associate Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital
City
ARAK
Postal code
Phone
+98 86 3313 5075
Fax
Email
jamilian.hr@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
HamidReza Jamilian
Position
Board of Psychiatry
Other areas of specialty/work
Street address
Amir Kabir Hospital
City
ARAK
Postal code
Phone
+98 86 3313 5075
Fax
Email
jamilian.hr@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Jamilian
Position
Board of Psychiatry ,Associate Professor
Other areas of specialty/work
Street address
Amir kabir Hospital
City
ARAK
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)