Protocol summary
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Study aim
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Investigating the effect of vitamin D suppositories on the sexual function of postmenopausal women
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Design
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In this study, 105 postmenopausal women (with inclusion criteria) will be recruited in the study. Using a simple randomization method, participants will be assigned in three study groups. To execute simple randomization method, the assignment sequence will be written before the beginning of the research, and then participants will be assigned in one of three groups of intervention, placebo and control.
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Settings and conduct
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Participants of the study will be selected among the clients of the comprehensive health centers of Bouyin Zahra.for the purpose of blinding, the assignment and coding sequence will be written by a person who is not in the research group and the codes will be concealed until the end of the analysis. in this way, participants, researcher and analysor will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: postmenopausal women, the absence of other diseases of the gland, such as diabetes and ...
Exclusion criteria: hormone therapy, stressful experience during the last 3 months
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Intervention groups
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There is three study groups: intervention group receiving vitamin D3 suppositories; control group receiving placebo suppositories, and control group receiving no intervention.
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Main outcome variables
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Postmenopausal women's Sexual function
General information
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Reason for update
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The record is updated to report actual start/end recruitment date and trial completion date.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180704040346N1
Registration date:
2018-10-13, 1397/07/21
Registration timing:
prospective
Last update:
2022-01-06, 1400/10/16
Update count:
1
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Registration date
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2018-10-13, 1397/07/21
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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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2018-10-23, 1397/08/01
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Expected recruitment end date
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2019-02-20, 1397/12/01
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Actual recruitment start date
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2019-08-01, 1398/05/10
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Actual recruitment end date
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2020-05-30, 1399/03/10
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Trial completion date
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2020-08-30, 1399/06/09
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Scientific title
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Effect of vitamin D on sexual function in postmenopausal women
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Public title
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Effect of vitamin D supplements on sexual function
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
One year after experiencing the last menstrual cycle
The absence of other diseases of the glands such as Kushnig disease, diabetes, ..
Exclusion criteria:
Use of vaginal drugs
Having a moderate to severe infection
Hormone Therapy
Stressful experience during the last quarter
There are abnormalities or surgery
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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
- Data analyser
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Sample size
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Target sample size:
105
Actual sample size reached:
105
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants of the study will be selected among the clients of the comprehensive health centers of Boyeen Zahra, Qazvin. Using simple randomization method, random allocation of samples will be done in three groups. for simple randomization method, the assignment sequence will be written before the start of the research. Given that the three groups will be studied, each letter will be assigned to one group (A suppository of vitamin D3, B group of placebo and C of the control group with routine care). Randomization is performed using the random allocation software. According the assignment sequence, the type of intervention will be written inside Opaque envelopes. Questionnaires will be encoded with the same sequence. In this case, a questionnaire with the same code will be completed for the person receiving the code 1 intervention.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study triple blinding will be performed. For this purpose, suppositories containing the drug and placebo will be prepared by the pharmaceutical company and will be packed anonymously with codes, so that the participants, the provider and the assessor (researcher) and the statistical analyst will not know the suppository type associated with each code (triple blinding). After the study and statistical analysis, the drug codes will be received from the pharmaceutical company.
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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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2018-09-16, 1397/06/25
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Ethics committee reference number
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IR.QUMS.REC.1397.117
Health conditions studied
1
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Description of health condition studied
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sexual function
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ICD-10 code
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F66.2
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ICD-10 code description
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N95. Sexual relationship disorder
Primary outcomes
1
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Description
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Sexual Function
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Timepoint
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Before the intervention, immediately after the intervention, one and two months after the end of the intervention
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Method of measurement
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using Female Sexual Function Index (FSFI)
Intervention groups
1
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Description
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Intervention group: The vaginal suppository of vitamin D is administered at a dose of 1000 units for 8 weeks; one suppository every night in the first two weeks, and one suppository every two nights the next six weeks. The main base of the suppository is mono, di, and triglyceride named AM-15 suppository synthesized by Gattefosse France. Base melting point is 34-36 degrees. Suppositories will be produced by melting and molding under the supervision of a pharmacist and will be produced by pharmaceutical experts from the pharmaceutical laboratory of the Faculty of Pharmacy of Mashhad. Each drug suppository weighs 1 gram and contains 1000 units of vitamin D. The superstructures have a sufficient mechanical strength and a smooth, uniform, whitewashed surface. After making suppositories, put them in the right amount in tight plastic packaging and placed in plastic containers at a temperature below 25 degrees, preferably kept in the refrigerator
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Category
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Treatment - Drugs
2
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Description
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Control group: placebo vaginal suppositories will be administered in placebo group with a similar treatment protocol of intervention group. Pharmacological properties and the manufacturing process of placebo suppositories are quite similar to the intervention group suppositories, except that in placebo supplements, the vitamin D will not be added.
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Category
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Placebo
3
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Description
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Control group: No intervention will be implemented. This group will receive routine heath cares for elders.
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Category
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N/A
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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Qazvin 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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Not applicable
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Title and more details about the data/document
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Data from the research results in the post-publication of the resulting research paper will be uploaded as a supplementary file of the original files
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When the data will become available and for how long
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After the end of the study, and simultaneously publishing the results
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To whom data/document is available
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Free access
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Under which criteria data/document could be used
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In case of correspondence with the author and the need to analyze beyond the objectives of the present study
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From where data/document is obtainable
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Corresponding with the responsible person
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What processes are involved for a request to access data/document
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To email z.sarebani@qums.ac.ir/Mid2017sarebani@ gmail.com
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Comments
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