The objective of the present randomized controlled trial is to assess the effect of vitamin D injection on depressive symptoms in subjects have vitamin D deficiency. At first Depressed mood was judged with the Beck Depression Inventory (BDI 2) .Subjects with BDI score >17 were included and their serum Calcium, Phosphrous , parathyroid hormone (PTH) and serum 25(OH) Vitamin D were measured. Subjects with serum 25(OH)Vitamin D<40 nmol/L were selected and assigned to 3 groups. 2 groups Received 300.000 and 150.000 IU vitamin D injection and one group had no treatment .After 3 months all tests were done to determine the effect of vitamin D injection on depressive symptoms in subjects have vitamin D deficiency.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105306641N1
Registration date:2011-10-16, 1390/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Laleh Nabizadeh Asl
Name of organization / entity
Yazd University of Medical Sciences and Health Services (Shahid Sadoogi Yazd)
Country
Iran (Islamic Republic of)
Phone
+98 143611302
Email address
l.nabizade@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoogi University of Medical Sciences and Health Services
Expected recruitment start date
2011-04-09, 1390/01/20
Expected recruitment end date
2012-03-15, 1390/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between efficiency of two different doses of vitamin D injection in depressed patients with vitamin D deficiency on depressive symptoms
Public title
Comparison between efficiency of two different doses of vitamin D injection in depressed patients with vitamin D deficiency on depressive symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with depression and serum 25(OH)D levels <40 nmol/L; no pregnancy and lactation, lack of vitamin and mineral supplementation and antidepressant drugs, without any thyroid ,CVD, kidney diseases. Exclusion criteria: Using vitamin and mineral supplementation and antidepressant drugs.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Shahid Sadoogi University of Medical Sciences and Health Services
Street address
Bahonar sq
City
Yazd
Postal code
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
135640
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Beck Depression score
Timepoint
Before and 3 months after intervention
Method of measurement
Beck Depression Inventory2 score
2
Description
serum 25-hydoxy vitamin D [25-(OH) D]
Timepoint
Before and 3 months after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
serum Calcium
Timepoint
Before and 3 month after intervention
Method of measurement
laboratory
2
Description
serum Phosphrous
Timepoint
Before and 3 month after intervention
Method of measurement
laboratory
3
Description
PTH
Timepoint
Before and 3 month after intervention
Method of measurement
ELISA
Intervention groups
1
Description
1. 300000 IU Vitamin D injection
Category
Treatment - Drugs
2
Description
3. no treatment
Category
N/A
3
Description
2. 150000 IU Vitamin D injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamolanbia Clinic
Full name of responsible person
Laleh Nabizadeh Asl
Street address
Talegani blvd.
City
Yazd
2
Recruitment center
Name of recruitment center
Farhangian Health center
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari
Street address
Bahonar sq.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences and Health Services
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
Yazd University of Medical Sciences and Health Services
Full name of responsible person
Dr Mojtaba Yassini Ardekani
Position
Psychologist
Other areas of specialty/work
Street address
Yazd University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
+98 31516515
Fax
Email
yassiniard@yahoo.com , yassini@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari Khosravi
Position
PHD, nutritionist
Other areas of specialty/work
Street address
Bahonar sq.
City
Yazd
Postal code
Phone
+98 131531467
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences and Health Services
Full name of responsible person
Laleh Nabizadeh Asl
Position
MS student of Health Science in Nutrition
Other areas of specialty/work
Street address
Yazd University of Medical Sciences and Health Services, Daneshju blvd
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)