Investigating the effect of vitamin e on depression and anxiety in postmenopausal women
Design
Clinical trial with control group, double-blind, randomized
Settings and conduct
This study is a double-blind clinical trial (researcher and patient) that the drug and placebo are coded by a third person who does not know about the study.Postmenopausal women referred to the menopause clinic of Imam Khomeini Hospital in Ahvaz (samples) are divided into two groups of odd and even using a table of random numbers, where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
At least one year passed since the last menstruation.
Menopausal Married women.
Educated.
Age between 45-65 years.
Earn a score 10-29 from Beck Depression Questionnaire for both groups.
Earn a score 8-25 from Beck Anxiety Questionnaire for both groups.
Exclusion criteria:
Consumption of vitamins and minerals, antidepressants and diuretics in the last 3 months.
Smoking history, using drugs and alcohol during the last 3 months.
History of mental or physical illness.
Occurrence of an unfortunate event during the last 6 months.
Intervention groups
Intervention group: 44 Menopause women with inclusion criteria that vitamin E made by Zahravi Company of Tabriz is given 400 units daily for 8 weeks. Control group: Menopause women who have the same conditions as the intervention group, but in the control group, placebo (corn oil) made by Zahravi Company of Tabriz is used.
Main outcome variables
Depression and anxiety of postmenopausal women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046719N1
Registration date:2020-12-04, 1399/09/14
Registration timing:prospective
Last update:2020-12-04, 1399/09/14
Update count:1
Registration date
2020-12-04, 1399/09/14
Registrant information
Name
Sara Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
soltani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Vitamin e on Depression and Anxiety in Postmenopausal Women
Public title
The Effect of Vitamin e on Depression and Anxiety in Postmenopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year passed since the last menstruation.
Menopausal Married women.
Educated.
Ages between 45-65 years.
Earn a score 10-29 from Beck Depression Questionnaire for both groups.
Earn a score 8-25 from Beck Anxiety Questionnaire for both groups.
Exclusion criteria:
Consumption of vitamins and minerals, antidepressants and diuretics in the last 3 months.
Smoking history, using drugs and alcohol during the last 3 months.
History of mental or physical illness.
Occurrence of an unfortunate event during the last 6 months
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 88 Menopause women who are eligible for the study are divided into even and odd groups using a random number table. The samples are divided into two groups of odd and even using a table of random numbers. Each sample is given an envelope with the code (1 or 2) that the drug and placebo are coded by a third person who does not know about the study where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks (medicine and placebo are made by Tabriz Zahravi Pharmaceutical Company). If even numbers (0,2,4,6,8) are selected using a random number table, the envelope with code 1 is given to the samples and if odd numbers (1,3,5,7,9)are selected using a random number table, the envelope with code 2 is given to the samples.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding and coding of drugs and placebos (vitamin e and corn oil) is done by a third person who does not know about the research. And the required number of each drug and placebo is poured separately in packages of same shape and code 1 or 2 is given. The samples and the researcher do not know the nature of the packages until the end of the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.AJUMS.REC.1398.929
Health conditions studied
1
Description of health condition studied
Depressive and Anxiety Disorder
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Beck Anxiety Inventory
2
Description
Depression
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The vitamin e made by Zahravi Company of Tabriz 400 unit once daily for eight weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule containing corn oil made by Zahravi Company of Tabriz once daily for eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Menopausal clinic of Imam Khomeini
Full name of responsible person
Sasan Mogahi
Street address
Azadegan Street, Imam Khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
Golestan Blv, Esfand Ave., Ahvaz Jundishapur University of medical Science, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6157941357
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Soltani
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing And Midwifery Department,Ahvaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
8513736871
Phone
+98 61 3373 8331
Email
soltani.s@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing And Midwifery Department,Ahvaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155686453
Phone
+98 61 3373 8331
Email
Abbaspoor_z762@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Soltani
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing And Midwifery Department,Ahvaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
8513736871
Phone
+98 61 3373 8331
Email
soltani.s@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Demographic information of individuals and data before and after the intervention is reported without mentioning the name
When the data will become available and for how long
Access started in 2021
To whom data/document is available
Only researchers in the field of medical universities
Under which criteria data/document could be used
It can only be used in similar research
From where data/document is obtainable
Researcher's personal email
What processes are involved for a request to access data/document
This is done by sending an email to the researcher.