Protocol summary
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Study aim
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Investigating the effect of vitamin e on depression and anxiety in postmenopausal women
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Design
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Clinical trial with control group, double-blind, randomized
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Settings and conduct
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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 NajafAbad (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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group: 46 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.
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Main outcome variables
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Depression and anxiety of postmenopausal women
General information
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Reason for update
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increasing the number of samples
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200307046719N1
Registration date:
2020-12-04, 1399/09/14
Registration timing:
prospective
Last update:
2024-01-03, 1402/10/13
Update count:
1
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Registration date
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2020-12-04, 1399/09/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-21, 1399/10/01
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Expected recruitment end date
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2021-02-19, 1399/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the Effect of Vitamin e on Depression and Anxiety in Postmenopausal Women
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Public title
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The Effect of Vitamin e on Depression and Anxiety in Postmenopausal Women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old to 65 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
92
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A total of 92 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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-24, 1398/12/05
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Ethics committee reference number
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IR.AJUMS.REC.1398.929
Health conditions studied
1
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Description of health condition studied
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Depressive and Anxiety Disorder
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ICD-10 code
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F41.2
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ICD-10 code description
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Mixed anxiety and depressive disorder
Primary outcomes
1
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Description
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Anxiety
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Timepoint
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Before the intervention and eight weeks after the intervention
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Method of measurement
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Beck Anxiety Inventory
2
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Description
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Depression
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Timepoint
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Before the intervention and eight weeks after the intervention
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Method of measurement
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Beck Depression Inventory
Intervention groups
1
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Description
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Intervention group: The vitamin e made by Zahravi Company of Tabriz 400 unit once daily for eight weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsule containing corn oil made by Zahravi Company of Tabriz once daily for eight weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Demographic information of individuals and data before and after the intervention is reported without mentioning the name
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When the data will become available and for how long
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Access started in 2021
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To whom data/document is available
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Only researchers in the field of medical universities
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Under which criteria data/document could be used
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It can only be used in similar research
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From where data/document is obtainable
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Researcher's personal email
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What processes are involved for a request to access data/document
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This is done by sending an email to the researcher.
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Comments
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