1- Objectives :Epidemiologic studies have shown that serum vitamin D is lower in patients with depression. The aim of this study is to determine effects of vitamin D supplementation on depression severity and inflammatory and oxidative factors in patients with major depressive disorder.
2-Design: Double blind randomized controlled trial.
3- Setting and conduct: Forty 18-65 year old patients with a diagnosis of major depressive disorder will be randomly allocated in two groups to receive 20 mg fluoxetine either alone or plus 1500 IU vitamin D for 8 weeks. Depression severity will be measured at baseline and after weeks 2, 4, 6, 8. Ten mL of venous blood sample will be obtained at baseline and after intervention and serum CRP and IL-6 and plasma total antioxidant will be measured.
4- Participants: Forty 18-65 year old patients with a diagnosis of major depressive disorder who were free of medication.
5- Intervention: 20 mg fluoxetine plus 1500 IU vitamin D or 20mg fluoxetine plus Placebo for 8 weeks.
6- Main outcome measures variables: Depression severity, serum C-reactive protein, Serum IL-6, plasma total antioxidant capacity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201072394N6
Registration date:2012-04-25, 1391/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-25, 1391/02/06
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-10-07, 1390/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on depression severity, inflammatory and oxidative markers in major depressive disorder disorder
Public title
Effect of vitamin D in major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate;
Clinical diagnosis of major depressive disorder;
A score ≥15 in the 17-item Hamilton Depression Rating Scale;
Age 18 – 65 years;
Good health status based on medical history;
No antidepressant or dietary supplement use during the previous two months.
Exclusion criteria:
Substance abuse;
Pregnancy and lactation.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
2402
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32.2
ICD-10 code description
Major depression
Primary outcomes
1
Description
Depression severity
Timepoint
At baseline, weeks 2, 4, 6, 8
Method of measurement
Hamilton Depression Rating Scale
Secondary outcomes
1
Description
C-reactive protein
Timepoint
At baseline, after weeks 2, 4, 6, 8.
Method of measurement
ELISA
2
Description
Total antioxidant capacity
Timepoint
8 weeks
Method of measurement
FRAP
3
Description
IL-6
Timepoint
At baseline, after weeks 2, 4, 6, 8.
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: 20 mg fluoxetine plus 1500 IU vitamin D daily after lunchfor 8 weeks
Category
Other
2
Description
Placebo group:
20 patients will receive 20 mg fluoxetin and placebo for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Psychiatry Hospital
Full name of responsible person
Dr.Mahdi Tehrani-Doost
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
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, Tehran 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
Tehran University of Medical Science
Full name of responsible person
Nayereh Khoraminya
Position
Student
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
khoraminya@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences, #60 Alvand Street, Argantin Square.
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
sh_jazayeri@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Shima Jazayeri
Position
Assistant Professor
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
sh_jazayeri@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)