1. Home
  2. Approved trials
  3. » فارسی

The effect of vitamin D addition on treatment response in patients with schizophrenia in zare hospital

Protocol summary

Summary
Objectives: The purpose of the present study is to assess possible correlations between serum concentrations of vitamin D and disease activity in patients with schizophrenia treated with atypical antipsychotic except clozapine. Study Design and Population: This randomized clinical trial will be conducted at the Zare Mental Health Center, Sari, Iran. Eighty schizophrenic patients based on DSM-IV TR criteria will be included in the study if they are aged between 18 to 65 years, treated with atypical antipsychotic drugs except clozapine and Vitamin D deficiency (serum vitamin D concentrations less than 30 ng/ml) .Patients with Acute renal failure, hepatic failure, parathyroid disease and consumption of vitamin D, parathyroid hormone, calcium, and phosphorous supplements will be excluded from study. Intervention: If the patient meets our inclusion criteria, he is entered in the study. Randomization was applied for each treatment group(1:1).In Group A, 600000 IU vitamin D supplementation is added intramuscular to standard atypical antipsychotic drug regimens monthly for three months. In Group B, as control group, is received only standard atypical antipsychotic drug regimens. Patients in second group will be supplemented with vitamin D after the 3 months period. Measurements and outcomes: At the baseline visit and after three months, blood samples are drawn for analysis of serum vitamin D, calcium, phosphorous, creatinine, BUN and routine liver function tests. Schizophrenic symptoms are evaluated with Positive and Negative Syndrome Scale (PANSS) at baseline and monthly for three months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201210163014N6
Registration date: 2013-05-25, 1392/03/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-25, 1392/03/04
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mazandaran University of Medical Sciences
Expected recruitment start date
2013-02-28, 1391/12/10
Expected recruitment end date
2015-02-28, 1393/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D addition on treatment response in patients with schizophrenia in zare hospital
Public title
The effect of vitamin D addition on treatment response in patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Schizophrenic patients based on DSM-IV TR criteria ;aged between 18 to 65 years; treated with atypical antipsychotic drugs except clozapine ; Vitamin D deficiency (serum vitamin D concentrations less than 30 ng/ml) . Exclusion criteria: Patients with Acute renal failure; hepatic failure; parathyroid disease and consumption of vitamin D; parathyroid hormone; calcium and phosphorous supplements
Age
From 19 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
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
The ethic committee of Mazandaran University of Medical Sciences and health services (MAZUMS)
Street address
18 KM Kazarabad Road, The Campus of Mazandaran University of Medical Sciences and health services (MAZUMS)
City
Sari
Postal code
Approval date
2013-02-02, 1391/11/14
Ethics committee reference number
911114

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20.6
ICD-10 code description
A disorder in which there is an insidious but progressive development of oddities of conduct, inability to meet the demands of society, and decline in total performance. The characteristic negative features of residual schizophrenia (e.g. blunting of affe

Primary outcomes

1

Description
Change in Positive and Negative Syndrome Scale total score (PANSS)
Timepoint
Baseline and first,second,third month
Method of measurement
PANSS Questionnaire

Secondary outcomes

1

Description
Serum vitamin D concentration
Timepoint
Baseline and third month
Method of measurement
ELISA

Intervention groups

1

Description
In Group A, 600000 IU vitamin D supplementation is added intramuscular to standard atypical antipsychotic drug regimens monthly for three months.
Category
Treatment - Drugs

2

Description
In Group B, as control group, is received only standard atypical antipsychotic drug regimens. Patients in second group will be supplemented with vitamin D after the 3 months study period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare Mental Health Center
Full name of responsible person
Dr. Narjes Hendouei
Street address
5 KM Neka-Sari Road
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Shahram Ala
Street address
18 KM Khazarabad Road, Faculty of pharmacy, Mazandaran University of Medical Science
City
Sari
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,Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Shima Mamashli
Position
Pharmacy student
Other areas of specialty/work
Street address
18 KM Khazarabad Road,Faculty of pharmacy, Mazandaran University of Medical Sciences
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
shima.mamashli67@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Narjes Hendouei
Position
Clinical pharmacy specialist, Assistant professor
Other areas of specialty/work
Street address
18 KM Kazarabad Road ,Faculty of pharmacy, Mazandaran University of Medical Sciences
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
+98 15 1354 3084
Email
hendoieen@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
dr.Narjes Hendouei
Position
Clinical pharmacy specialist, Assistant professor
Other areas of specialty/work
Street address
18 KM Kazarabad Road ,Faculty of pharmacy, Mazandaran University of Medical Sciences
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
+98 15 1354 3084
Email
hendoieen@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...