Protocol summary

Study aim
Determining the effect of supplementation with nanoselenium on the expression of JAK2, STAT3, SRC and indoleamine 2 and 3 dioxygenase genes, serum total antioxidant capacity, serum glutathione peroxidase, malondialdehyde and depressive symptoms in patients with major depressive disorder
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 50 patients with MDD, randomized blocks
Settings and conduct
The study will take place at the Imam Khomeini Hospital Complex. Patients will be randomly assigned to one of two groups: 1. nanoselenium (containing 55 micrograms of selenium) and sertraline (25 people); and 2. placebo (containing corn starch) and sertraline (25 people) for 12 weeks. The researcher, neuropsychologist, individuals involved in blood collection and sample evaluation, and the person performing statistical analysis will all be blinded.
Participants/Inclusion and exclusion criteria
Patients with major depressive disorder referring to Imam Khomeini Hospital Complex (RA) who are in the age group of 18 to 50 years with a body mass index of at least 18.5 and at most 30 kg/m2 and not using antidepressants and nutritional supplements and they do not suffer from conditions that affect their nutritional status, such as chronic diseases, pregnancy and breastfeeding.
Intervention groups
Intervention: Nano-selenium (55 micrograms selenium), Control: placebo capsule (corn starch)
Main outcome variables
SRC gene expression; JAK2 gene expression; STAT3 gene expression; Gene expression of indoleamine 2 and 3 dioxygenase; serum total antioxidant capacity; serum glutathione peroxidase level; serum Malondialdehyde level; Hamilton Depression Rating Scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091114002709N62
Registration date: 2023-07-29, 1402/05/07
Registration timing: prospective

Last update: 2023-07-29, 1402/05/07
Update count: 0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-22, 1402/05/31
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nano-selenium supplementation on JAK2, STAT3, SRC and indoleamine 2,3-dioxygenase gene expression, serum total antioxidant capacity, serum glutathione peroxidase and malondialdehyde levels, and depressive symptoms in patients with major depressive disorder; A triple-blind randomized controlled trial
Public title
Nano-selenium in major depressive disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from major depressive disorder based on DSM-V (Structured Clinical Interview for DSM Disorders (SCID)) Being in the age group of 18 to 50 years Not using antidepressants (including sertraline, fluoxetine, citalopram, or amitriptyline) for 3 months or more before the start of the study Body mass index of at least 18.5 kg/m2 and a maximum of 30 kg/m2 Desire to participate in the study and complete the informed consent form based on knowledge and consent to participate in the study
Exclusion criteria:
History of autoimmune, neurological, thyroid, cancer, kidney, liver, cardiovascular or respiratory diseases, psychotic and bipolar disorders, neurodegenerative disorders A history of any disease that causes a change in a person’s dietary habits and physical activity High risk of suicide Pregnancy and breastfeeding Taking nutritional supplements such as antioxidant or omega 3 or vitamin D supplements less than 6 weeks before the start of the study alcohol consumption Smoking Following a specific dietary pattern Participating in another study within the past two months
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into intervention and placebo groups in a ratio of 1:1 using random blocks (www.randomization.com) by a research assistant not involved in the study. For this purpose, the codes A and B will be assigned to the supplement or the placebo, and the researchers will not know which code is for the placebo or the supplement until the end of the study. In the method of using random blocks, we can create blocks and assign codes equally to each block. If we specify two codes in each block, we can make two possible sequences AB and BA. When we randomize the blocks, the same codes can be assigned to each group. If the block size is four, we can make six possible sequences (AABB, ABAB, ABBA, BAAB, BABA, BBAA) and then randomize them. The drawback of this method is that the presenter can predict the code of the next person. For example, if the block size is two, we can easily know the fact that B comes after A, or if the block size is four, we can predict what the last code will be. This is against the principle of randomization. To solve this problem, the research assistant who performs the randomization has hidden the block size from us and uses randomly mixed block sizes. For example, the block size can be two, four, and six. The codes will be provided to the researcher in a sealed envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Supplement and placebo will be prepackaged based on random codes. The researcher, the neuropsychologist, the people involved in taking blood and evaluating the samples, and the person who will perform the statistical analysis will not be aware of whether the person is in the intervention or control group. Nano-selenium supplement will be prepared at the Medical Plants Research Center of Shahrekord University of Medical Sciences. The placebo contains corn starch powder and will be prepared by the Medical Plants Research Center of Shahrekord University of Medical Sciences. The nano-selenium supplement or the placebo provided to the participants will be completely similar in terms of size, shape, packaging, smell and taste.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2023-06-13, 1402/03/23
Ethics committee reference number
IR.IUMS.REC.1402.206

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent

Primary outcomes

1

Description
SRC gene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR

2

Description
JAK2 gene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR

3

Description
STAT3 gene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR

4

Description
Indoleamine 2 and 3 dioxygenase gene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR

Secondary outcomes

1

Description
Serum total antioxidant capacity
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Colorimetric

2

Description
Serum glutathione peroxidase level
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Colorimetric

3

Description
Serm malondialdehyde level
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Colorimetric

4

Description
Depressive symptoms
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Hamilton Depression Rating Scale

Intervention groups

1

Description
Intervention group: Nanoselenium capsule containing 55 micrograms of selenium; Control group: Placebo (corn starch)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex (RA)
Full name of responsible person
Farnaz Etesam
Street address
Imam Khomeini Hospital Complex (RA), Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 0033
Email
fa.etesam@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway,
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 2030
Email
rezafalak@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat expressway
City
Tehran
Province
Tehran
Postal code
1449614525
Phone
+98 21 8860 2218
Fax
+98 21 8860 2219
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat expressway
City
Tehran
Province
Tehran
Postal code
1449614525
Phone
+98 21 8860 2218
Fax
+98 21 8860 2219
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat expressway
City
Tehran
Province
Tehran
Postal code
1449614525
Phone
+98 21 8860 2218
Fax
+98 21 8860 2219
Email
farzadshidfar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to use the data to conduct another study or use in patients
From where data/document is obtainable
Dr Farzad Shidfar shidfar.f@iums.ac.ir
What processes are involved for a request to access data/document
Request by e-mail along with providing a complete explanation of why the data is needed
Comments
Loading...