Objective: The aim of this study is to determine the effect of vitamin D supplementation on severity depression and metabolic status among patients with major depressive disorder. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria, aged 20 to 50 years, the least score 12 on BDI-II scoring system. Exclusion Criteria: Pregnancy, alcohol and drug abuse within 6 months prior to the start of the project, psychosis, mental retardation, depression caused by physical illness or drugs and substances, any type of severe, chronic physical illness, chronic physical illness and any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc) will be excluded. Population and sample size: 40 patients with major depressive disorder of eligible and referred to Kargarnejad Hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either the vitamin D supplements (intervention group: n=20) or placebo (control group: n=20). Fasting blood samples will be taken at baseline and after 8-wk intervention. Intervention: 8 weeks (November 1, 2014-December 31, 2014). Outcomes: Fasting plasma glucose, serum insulin, hs-CRP, insulin resistance, lipid profiles (total cholesterol, HDL-cholesterol and triglycerides) will be measured at the beginning and end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412065623N29
Registration date:2014-12-19, 1393/09/28
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2014-11-01, 1393/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation on insulin resistance and inflammatory factor in patients with depression
Public title
Effect of supplementation in treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria; aged 20 to 50 years; the least score 12 on BDI –II scoring system.
Exclusion Criteria: Alcohol consumption and drug abuse during the 6 months before the start of intervention; pregnant; psychotic symptoms; mental retardation; depression caused by physical diseases or taking medications and substances; any type of severe and chronic physical diseases; subjects with acute and severe medical illnesses; the incidence of any severe mental disorder (suicidal thoughts, psychotic symptoms, symptoms of mania phase, etc).
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
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
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
4230/1/5/29/p
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
3
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
5
Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
6
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin D pearl, 50000 IU, weekly, for 8 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo pearl, weekly, for 8 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad Hospital
Full name of responsible person
Zatollah Asemi
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
City
Kashan
Postal code
+98
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
City
Kashan
Postal code
+98
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)