Determining the effect of vitamin E supplementation on sleep quality of postmenopausal women
Design
A randomized controlled clinical trial with parallel groups, triple-blind (researcher, participant, and data and safety monitoring board), phase 3, involving 66 postmenopausal women. Block randomization will be used for randomization, employing the website www.sealedenvelope.com.
Settings and conduct
This study will be conducted on 66 postmenopausal women referring to health centers in East and West Ahvaz. Postmenopausal women will be screened based on inclusion and exclusion criteria, and if they meet the criteria and are willing to participate in the study, written informed consent will be obtained and initial assessments will be performed. Participants will receive vitamin E supplements and placebo in a permutation randomization block method with a 1:1 allocation sequence in two groups.
Participants/Inclusion and exclusion criteria
Women with physiological menopause who have been at least 10 years post-menopausal, who are free of physical or mental illnesses, and who have scored more than 5 on the Pittsburgh Sleep Quality Questionnaire will be included in the study. People who have taken sleep medications, vitamin E, or other supplements within the three months prior to the study will not be included in the study.
Intervention groups
IIntervention group: will consume 400 units of vitamin E supplements daily for 4 weeks.
Control group: will consume a similar placebo daily for 4 weeks
Main outcome variables
Sleep quality in postmenopausal women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240928063192N1
Registration date:2024-12-16, 1403/09/26
Registration timing:prospective
Last update:2024-12-16, 1403/09/26
Update count:0
Registration date
2024-12-16, 1403/09/26
Registrant information
Name
Masomeh Nikbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5227 1409
Email address
nikbakht.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin E supplementation on the sleep quality of postmenopausal women
Public title
The effect of vitamin E supplementation on the sleep quality of postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Age 45 to 65 years
Physiological menopause
A maximum of ten years have passed since the onset of menopause
Obtaining a score of more than 5 in the Pittsburgh Sleep Quality Questionnaire
Absence of depression according to the Beck depression questionnaire
No smoking or alcohol consumption
Exclusion criteria:
Simultaneous participation in other clinical trials
Not taking vitamin E supplements or other supplements in the last three months
Chronic diseases such as heart diseases, diabetes, gastrointestinal diseases, etc
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two intervention and control groups using a permuted block randomization method with block sizes of two and six using the randomization website www.sealedenvelope.com. Sealed opaque envelopes will be used to conceal randomization.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and placebo will be made in exactly the same shape, size, and color, and the researcher, participants, and statistician will be blinded to group assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Ahvaz University of Medical Sciences
Street address
Esfand Street, Golestan Blvd, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-11-02, 1403/08/12
Ethics committee reference number
IR.AJUMS.REC.1403.419
Health conditions studied
1
Description of health condition studied
Sleep quality of postmenopausal women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality of postmenopausal women
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
The variables are measured by demographic information questionnaire, Pittsburgh sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the intervention group who meet the inclusion criteria will complete the demographic information form and the PSQI questionnaire after receiving a detailed explanation of the thesis project and providing informed consent before the intervention begins. The intervention will involve the daily consumption of 400 IU of vitamin E (one capsule per day) for a duration of 4 weeks. The 400 IU vitamin E capsules will be prepared in the Pharmaceutics Laboratory of the Faculty of Pharmacy, where vitamin E powder will be manually filled into plant-based capsules using precise tools and stored under dry and cool conditions to maintain quality. Additionally, all study participants will complete the questionnaires again in the 4th and 8th weeks after the start of the intervention.
Category
Treatment - Other
2
Description
In the control group, the intervention is administered by placebo. The placebo also contains dry bread powder, which is filled by the same device in capsules of the same size and color, which are completely similar in appearance to vitamin E supplements, and is given once daily for 4 weeks. 4 and 8 weeks after the start of the intervention, the questionnaires will be completed again by all study subjects.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
East and west Ahvaz Health Center
Full name of responsible person
Masoumeh Nikbakht
Street address
Golestan Blvd. Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3332 8375
Email
nikbakht.m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Research Affairs, Jundishapur University of Medical Sciences, Golestan Blvd, Opposite Central Building, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
itc@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
Masoumeh Nikbakht
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Esfand Street, Golestan Blvd, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 917 615 8978
Email
nikbakht.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Somaye Makvandi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Esfand Street, Golestan Blvd, Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 604 2247
Email
Somayemakvandi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoume Nikbakht
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Esfand Street, Golestan Blvd, Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 917 615 8978
Email
nikbakht.m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential
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
Yes - There is 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
Title and more details about the data/document
The results of the clinical study will be published in the form of an article
When the data will become available and for how long
Immediately after the publication of the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use with reference to the article
From where data/document is obtainable
nikbakhtalphamobile97@gmail.com
What processes are involved for a request to access data/document