Protocol summary

Study aim
Comparison of the effect of Saccharomyces Cerevisiae enriched with selenium and mineral selenium on postpartum depression and sexual satisfaction
Design
The present study is a controlled trial, phase 3, with three parallel groups, triple blind, which will be performed on 108 people in three groups. The research environment will be the health centers of Tabriz city.
Settings and conduct
This study will be performed in health centers in Tabriz. A member of the non-research team involved in the selection of samples will determine the random allocation sequence using a computer program. Closed opaque envelopes will be used numbered in order to conceal the allocation. Eligible individuals will be randomly assigned to three groups using block sizes of 3 and 6 blocks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women 18 years and older, Recent low-risk pregnancies, Having a care record at the nearest health center Exclusion criteria: Existence of prenatal depression, A score above 23 on the Edinburgh Questionnaire, History of depression or any other mental disorder, Death or hospitalization of the baby in the intensive care unit, Stillbirth, Hospitalization of the mother due to postpartum complications, Having chronic diseases such as liver and kidney disease, Having frequent miscarriages and having a history of infertility, Having a history of a child with a mental or physical disability, Allergy to fungi and yeast
Intervention groups
In this study, two groups will receive mineral selenium and Saccharomyces Cerevisiae enriched with selenium as the intervention groups and the third group will receive placebo as the control group.
Main outcome variables
Score of depressive symptoms before and after the intervention, Score of sexual satisfaction before and after the intervention.

General information

Reason for update
Acronym
مقایسه تاثیر مخمر ساکارومایسس سروزیه غنی شده با سلنیوم و سلنیوم معدنی بر افسردگی بعد از زایمان و میزان رضایت جنسی
IRCT registration information
IRCT registration number: IRCT20110606006709N23
Registration date: 2021-09-13, 1400/06/22
Registration timing: registered_while_recruiting

Last update: 2021-09-13, 1400/06/22
Update count: 0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-02, 1400/05/11
Expected recruitment end date
2021-11-30, 1400/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Saccharomyces Cerevisiae enriched with selenium and mineral selenium on postpartum depression and sexual satisfaction:A triple-blind randomized controlled trial
Public title
The effect of Saccharomyces Cerevisiae enriched with selenium and mineral selenium on postpartum depression and sexual satisfaction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women over 18 years who are in the first 15 to 90 days after giving birth. Willingness to participate in research Having a record of care in health centers
Exclusion criteria:
A score above 23 on the Edinburgh Questionnaire History of depression or any other mental disorder Death or hospitalization of the baby in the intensive care unit Stillbirth Hospitalization of the mother due to postpartum complications Having chronic diseases such as liver and kidney disease Allergy to fungi and yeast Loss of loved ones between two months before delivery and two months after delivery Having frequent miscarriages and having a history of infertility Having a history of a child with a mental or physical disability Divorce over the past three months
Age
From 18 years old to 45 years old
Gender
Female
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: 108
More than 1 sample in each individual
Number of samples in each individual: 36
Target sample size:108
Randomization (investigator's opinion)
Randomized
Randomization description
Breastfeeding women with mild to moderate depression scores using a randomized blocking method with a size of three or six blocks using RAS (Random Allocation Software) with a 1: 1: 1 allocation ratio in The three groups receiving Saccharomyces cerevisiae enriched with selenium, mineral selenium and placebo will be included. To hide the allocation, the group name will be placed inside a numbered consecutive matte envelope. Envelope preparation and random allocation sequencing will be performed by the non-research person.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drugs and their placebo will be prepared by the pharmaceutical company in a completely similar way in terms of shape, color and smell. The researcher, participants, data analyst, and outcome reviewer are unaware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2,Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR. TBZMED.REC.1400.342

Health conditions studied

1

Description of health condition studied
Postpartum Depression
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance

Primary outcomes

1

Description
Depression score
Timepoint
Before and after the intervention at intervals of 8 weeks
Method of measurement
Edinburgh Depression Inventory

2

Description
Sexual satisfaction
Timepoint
Before and after the intervention at intervals of 8 weeks
Method of measurement
Sexual Satisfaction Questionnaire

Secondary outcomes

1

Description
Side events
Timepoint
During 8 weeks of intervention
Method of measurement
Side accident assessment form

Intervention groups

1

Description
Intervention group 1: Capsules containing Saccharomyces Cerevisiae enriched with selenium 200 micrograms, one for 8 weeks. Drugs will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi
Category
Treatment - Drugs

2

Description
Intervention group 2: Capsules containing mineral selenium 200 micrograms, one for 8 weeks. Drugs will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi.
Category
Treatment - Drugs

3

Description
Control group: Capsules containing placebo, one for 8 weeks. Placebo will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers selected in Tabriz
Full name of responsible person
Parnyan Rahimi
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Research department, third floor, central construction number 2,Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabrizt
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parnian Rahimi
Position
Student of master's degree in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
+98 41 3475 3906
Fax
+98 41 3475 3906
Email
parnian9797.md@gmail.com
Web page address
http://nursing.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 2699
Fax
+98 41 3479 6969
Email
mshahnazi@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parnian Rahimi
Position
Student of master degree in Tabriz
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery ,South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
9841344753906
Fax
+98 41 3479 6969
Email
parnian9797.md@gmail.com
Web page address
http://nursing.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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