The comparison of effectiveness of vitamin D3 supplement with placebo on reducing the rate of weight gain due to consuming of olanzapine in the women with psychiatric disorders.
The comparison of effectiveness the vitamin D3 supplement with placebo on reducing the rate of weight gain due to consuming olanzapine in the women with psychiatric disorders.
Inclusion criteria:women with psychiatric disorder;20-55 years old ;not pregnant;have not any medical illness;during consuming olanzapin have weight gain;her serum level of vitamin is normal range and having normal weight before receiving olanzapin.
Exclusion criteria:women with medical illness;poly cystic ovarian and women that received other drug that induced obesity. this study is on 50 women that have psychiatric disorder. this study is an interventional ,double blind,placebo control clinical trial which one group of them receive vitamin D3,and other group receive placebo every 2 week for 12 week. height, weight, wrist and BMI measured before and after investigation and then will be analyzed. The primary outcome are Weight,BMI,Wrist,Hip,Wrist hip ratio.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122520430N1
Registration date:2015-02-02, 1393/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Somayeh kaviyani Dastgerdi
Name of organization / entity
Jundishapur University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
kaviyani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of ahvaz University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of vitamin D3 supplement with placebo on reducing the rate of weight gain due to consuming of olanzapine in the women with psychiatric disorders.
Public title
The effect of vitamin D3 on the obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:women with psychiatric disorder;20-55 years old;not pregnant;have not any medical illness;during consuming olanzapin have weight gain;her serum level of vitamin is normal range.
Exclusion criteria:women with medical illness;poly cystic ovarian and women that receive other drug that induced obesity.
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Ahvaz University Of Medical Science.
Street address
Golestan street, West Coast Blvd, Ahvaz
City
Ahvaz
Postal code
Approval date
2013-07-27, 1392/05/05
Ethics committee reference number
ajums.rec.1393.347
Health conditions studied
1
Description of health condition studied
drug induced obesity
ICD-10 code
E66.1
ICD-10 code description
Use additional external cause code (Chapter XX), if desired, to identify drug.
Primary outcomes
1
Description
Weight,BMI,Wrist,Hip,Wrist hip ratio.
Timepoint
Befor and after intervention
Method of measurement
Befor and after intervention with Scales and meters
Secondary outcomes
1
Description
Nusea,Headache
Timepoint
Befor intervention
Method of measurement
During intervention repeatedly
Intervention groups
1
Description
Drug group:pearl 50000 unit, vitamin D3,that every 2 week prescribe to 12 week
Category
Treatment - Drugs
2
Description
Control : placebo of vitamin D3,that every 2 week prescribe to 12 week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital Of Ahvaz
Full name of responsible person
Kaviyani Somayeh
Street address
Golestan Hospital ,Golestan street ,West Coast Blvd ,Ahvaz.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Unversity Of Medical Science
Full name of responsible person
Dr.Nadereh Saki
Street address
Research Administration, Ahvaz Unversity Of Science, Ahvaz.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Unversity Of Medical Science
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
Ahvaz University Of Medical Science
Full name of responsible person
Kaviyani Somayeh
Position
Psychiatric Resident
Other areas of specialty/work
Street address
Golestan Hospital, Golestan Street, West Coast Blvd, Ahvaz.