Major depression is a common illness in the world and the various treatments used to treat depression or reduce its symptoms. ُSome studies have shown that zinc is concentrated in specific areas of brain and dietary zinc deficiency can influence homeostasis of zinc in brain and may predispose the individual to psychiatric disorders including depression. In this study, we will examine the effect of zinc supplementation on depression status. Patients with major depression referred to a psychiatrist who meet the inclusion criteria if willing are invited to participate in the study. Patients will randomly divided into two groups. In the first group, patients received a zinc sulfate capsule containing 25 milligrams of zinc plus previous medication and in the second group, a placebo plus each patient's previous medication is given for 12 weeks. After 6 and 12 weeks, in both groups depression will be examined based on the Beck and Hamilton questionnaire. In the beginning and at the end of study, a fasting blood sample (5 mL) is taken from all patients and plasma concentrations of zinc, Tumor Necrosis Factor-a, Interleukin-6 and Brain-derived Nerve Factor is determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110187836N1
Registration date:2011-11-06, 1390/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-06, 1390/08/15
Registrant information
Name
Javad Nasrollahzadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 6467
Email address
jnasrollahzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuroscience Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on depression and certain inflammatory cytokines depression in patients with major
Public title
Effect of zinc supplementation in major depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
- A diagnosis of major depressive disorder
- Have no current medical illness (diabetes, cancer, cardiovascular, inflammatory, liver or renal diseases)
- No antepartum or postpartum depression
- Current treatment with medication except for depressive disorder
- Current use of multivitamin-mineral supplement
Exclusion criteria:
- pregnancy or lactation
- any change in medication
- A diagnosis of a new medical illness during study
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Neurosience Research Center
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-03-04, 1390/12/14
Ethics committee reference number
t/1/044
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Depression
Timepoint
at the begining, after 6 and 12 weeks of supplementation
Method of measurement
Hamilton and Beck Depression Rating Scale
Secondary outcomes
1
Description
Plasma concentration of brain-derived growth factor
Timepoint
Before and after 12 weeks of treatment
Method of measurement
Biochemical assay
2
Description
Plasma concentration of Tumor Necrosis Factor-a
Timepoint
Before and after 12 weeks of treatment
Method of measurement
Biochemical assay
3
Description
Plasma concentration of Interleukin-6
Timepoint
Before and after 12 weeks of treatment
Method of measurement
Biochemical assay
Intervention groups
1
Description
Taking a Zinc sulfate capsule, 25 mg once a day for 12 weeks (intervention)
Category
Treatment - Drugs
2
Description
Taking a placebo capsule once a day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Clinical Nutrition and Diet therapy, Faculty of Nutrition Sciences and Food Technology
Full name of responsible person
Dr. M. Sabetkasaei
Street address
Neurosience Research Center, Shahid Beheshti University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Clinical Nutrition and Diet therapy, Faculty of Nutrition Sciences and Food Technology
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Ranjbar
Position
Master of Science
Other areas of specialty/work
Street address
Department of Clinical Nutrition and Diet therapy, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2237 6467
Fax
Email
alnaz_3000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Minoo M Shrazi
Position
MD, PhD (Nutrition)
Other areas of specialty/work
Street address
Department of Clinical Nutrition and Diet therapy, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2237 6467
Fax
Email
shiraziminoo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javad Nasrollahzadeh
Position
PhD (Nutrition)
Other areas of specialty/work
Street address
Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2237 6467
Fax
Email
jnasrollahzadeh@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)