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IRCT20180704040346N1 IRCT 2018-10-13 Qazvin University of Medical Sciences Effect of vitamin D supplements on sexual function Effect of vitamin D on sexual function in postmenopausal women 2018-10-23 anticipated 105 Complete https://irct.ir/trial/32457 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 sexual function. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: No intervention will be implemented. This group will receive routine heath cares for elders. Yes - There is a plan to make this available What will be shared: 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: After the end of the study, and simultaneously publishing the results To whom: Free access Conditions: In case of correspondence with the author and the need to analyze beyond the objectives of the present study Where to obtain: Corresponding with the responsible person How to obtain: To email z.sarebani@qums.ac.ir/Mid2017sarebani@ gmail.com Comments:
public Zinat Sarebani
Boyeen Zahra Health Care Network
Bouyin Zahra Iran (Islamic Republic of) 3413744345 +98 28 3422 2229 z.sarebani@qums.ac.ir Qazvin University of Medical Sciences scientific Zinat Sarebani
Boyeen Zahra Health Care Network
Boyeen Zahra Iran (Islamic Republic of) 3413744345 +98 28 3422 2229 z.sarebani@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) One year after experiencing the last menstrual cycle The absence of other diseases of the glands such as Kushnig disease, diabetes, .. 45 years 65 years Female Use of vaginal drugs Having a moderate to severe infection Hormone Therapy Stressful experience during the last quarter There are abnormalities or surgery F66.2 N95. Sexual relationship disorder Treatment - Drugs Placebo N/A 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 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. Control group: No intervention will be implemented. This group will receive routine heath cares for elders. 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). Qazvin University of Medical Sciences Approved 2018-09-16 Qazvin University of Medical Sciences Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery Qazvin Qazvin Iran (Islamic Republic of)