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The effect of vitamin D supplements on sexual satisfaction, function and self-efficacy among women in reproductive age.

Protocol summary

Study aim
The effect of vitamin D supplements on sexual satisfaction, function and self-efficacy among women in reproductive age.
Design
People enter the study who have low sexual function and satisfaction, and without depression. The sample size was determined 102 people (51people in controls and 51 people in case group) were calculated by statistical consltant and based on the previous studies . people with deficiency vitamin D who are dysfuction sexual are identified and then separate envelopes are placed A and B are box (A case group and control group B), and each participant will takes an envelope, the case group will be taken 1 tablet of vit D 600 unit daily for 12 weeks and to the control group will be taken 1 tablet of placebo daily for 12 weeks, and after12 weeks, vitamin D level is measured.To sample are again the sexual satisfaction and sexual function and sexual self-efficacy questionnaires. After completing the questionnaires, the scores are compared with scores of before intervention .
Settings and conduct
The sample of the study is all women refered to health centers affiliated to Ahwaz jundishapur University of medical sciences who are eligible to enter study at the time of the research
Participants/Inclusion and exclusion criteria
Entry criteria: Married, women of reproductive age, having sex with a partner, vitamin D level less than 30 ng / ml, junior grade less than 55.26, sexual satisfaction score less than 100,Exit criteria: Menopause, pregnancy, history of chronic diseases such as blood pressure, diabetes and hypothyroidism, immune defenses, antihypertensive drugs and antidepressants, menstrual disorder, lactation, vaginal infections and cervicitis
Intervention groups
In the intervention group, using tablet of vitD In the control group using placebo
Main outcome variables
Sexual satisfaction, function and sexual self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180117038413N1
Registration date: 2018-03-09, 1396/12/18
Registration timing: registered_while_recruiting

Last update: 2018-03-09, 1396/12/18
Update count: 0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
Naghme Ajeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3379 6534
Email address
ajeli.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-28, 1396/12/09
Expected recruitment end date
2018-05-30, 1397/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplements on sexual satisfaction, function and self-efficacy among women in reproductive age.
Public title
The effect of oral vitamin D supplementation on satisfaction, performance, and sexual self-efficacy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being married Women of reproductive age 18 - 45 years Having sex with spouse Being a single wife Literacy reading and writing The level of vitamin D is less than 30 ng / ml Sexual performance score is less than 26/55 Sexual satisfaction score less than 100
Exclusion criteria:
Menopause Pregnancy History or presence of chronic diseases such as blood pressure and diabetes, hypothyroidism and immune disorders Antihypertensive drugs and antidepressants Taking antipsychotics over the past 6 months Hormone replacement therapy Or contraceptive pills Moderate and severe depression Vaginal and cervicitis infections The occurrence of a horrible event (death of loved ones, incidents with disabilities) Menstrual irregularities Lactation
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done using random numbers And the coupled numbers obtained for group A the odds for group B are considered (Box A case group and box B control group)
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and volunteer Participant in this study is completely unaware of the drug or placebo supplements, and this is done by the pharmacist in the same packages and then encoded
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethice committee of Ahvaz University of Medical Sciences
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.AJUMS.REC.1396.812

Health conditions studied

1

Description of health condition studied
Disorder in sexual function and satisfaction ،
ICD-10 code
ICD-10 code description
sexual function

Primary outcomes

1

Description
Vit D
Timepoint
12 weeks
Method of measurement
Blood taking(before intervention and after intervention )

Secondary outcomes

1

Description
Sexual satisfaction
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Larson questionnaire

2

Description
Sexual function
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
FSFI questionnaire

3

Description
Sexual sell _ efficacy
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Sexual sell_ efficacy questionnaire

Intervention groups

1

Description
Intervention group: Tablet Vitamin D 600u daily for 12 weeks
Category
Treatment - Drugs

2

Description
Control group:Placebo,tablet 1 daily for 12 weeks Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 2 West
Full name of responsible person
Naghme Ajeli
Street address
South Soroush Ave, Khashayar،Health Center No 2 of West Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
6155745477
Phone
+98 61 3379 6534
Email
Ajeli.n@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvī
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 6333 4891
Email
itc@ajums.ac.ir
Web page address
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
Naghme Ajeli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Health Center No 2 of West, South Soroush, Khashayar
City
Ahvaz
Province
Khouzestan
Postal code
6155745477
Phone
+98 61 3379 6534
Email
Ajeli.n@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Position
Educational coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery،Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3733 6938
Email
mousavip2009@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naghme Ajeli
Position
Master of Midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fourth Floo ،Royal Palace Buildingr ،East 17th Stree ،Kianparst، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155993826
Phone
+98 61 3379 6534
Email
naghmeajeli@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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