Protocol summary

Study aim
Investigating the effect of vitamin D suppositories on the sexual function of postmenopausal women
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
There is three study groups: intervention group receiving vitamin D3 suppositories; control group receiving placebo suppositories, and control group receiving no intervention.
Main outcome variables
Postmenopausal women's Sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180704040346N1
Registration date: 2018-10-13, 1397/07/21
Registration timing: prospective

Last update: 2018-10-13, 1397/07/21
Update count: 0
Registration date
2018-10-13, 1397/07/21
Registrant information
Name
Zinat Sarebani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3378 2521
Email address
z.sarebani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on sexual function in postmenopausal women
Public title
Effect of vitamin D supplements on sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.QUMS.REC.1397.117

Health conditions studied

1

Description of health condition studied
sexual function
ICD-10 code
F66.2
ICD-10 code description
N95. Sexual relationship disorder

Primary outcomes

1

Description
Sexual Function
Timepoint
Before the intervention, immediately after the intervention, one and two months after the end of the intervention
Method of measurement
using Female Sexual Function Index (FSFI)

Secondary outcomes

empty

Intervention groups

1

Description
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
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

3

Description
Control group: No intervention will be implemented. This group will receive routine heath cares for elders.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Centers of Boyin Zahra
Full name of responsible person
Zinat Sarebani
Street address
Boyeen Zahra Health Care Network
City
Boyin Zahra
Province
Qazvin
Postal code
34137344345
Phone
+98 28 3422 2229
Email
z.sarebani@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Sarebani
Street address
Boyeen Zahra Health Care Network
City
Boyeen Zahra
Province
Qazvin
Postal code
3413744345
Phone
+98 28 3422 2229
Email
z.sarebani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Sarebani
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Boyeen Zahra Health Care Network
City
Bouyin Zahra
Province
Qazvin
Postal code
3413744345
Phone
+98 28 3422 2229
Email
z.sarebani@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Sarebani
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Boyeen Zahra Health Care Network
City
Boyeen Zahra
Province
Qazvin
Postal code
3413744345
Phone
+98 28 3422 2229
Email
z.sarebani@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Sarebani
Position
Master of Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Boyeen Zahra Health Care Network
City
Boyeen Zahra
Province
Qazvin
Postal code
3413744345
Phone
+98 28 3422 2229
Email
z.sarebani@qums.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
Not applicable
Title and more details about the data/document
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
When the data will become available and for how long
After the end of the study, and simultaneously publishing the results
To whom data/document is available
Free access
Under which criteria data/document could be used
In case of correspondence with the author and the need to analyze beyond the objectives of the present study
From where data/document is obtainable
Corresponding with the responsible person
What processes are involved for a request to access data/document
To email z.sarebani@qums.ac.ir/Mid2017sarebani@ gmail.com
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