Protocol summary

Study aim
Determining the effect of vitamin D on the sexual performance of women of reproductive age with type 2 diabetes referred to Isfahan Endocrine and Metabolism Research Center in 1403
Design
This study is a double-blind randomized clinical trial that is conducted on 100 women with type 2 diabetes of reproductive age who meet the inclusion criteria. The samples have insufficient levels of vitamins (10-30 ng/ml), which are randomly assigned to the intervention group (weekly prescription of Vitamin D 50000) and the control group (weekly placebo prescription) by random number table.
Settings and conduct
Women of reproductive age who are suffering from type 2 diabetes and have a document at Isfahan Endocrine Center are included in the study. and who Uses a random number table, based on the number, even numbers are placed in the intervention group and odd numbers are placed in the control group (Weekly administration for 12 weeks) and the researchers and participants are blinded. Finally, the questionnaire is completed.
Participants/Inclusion and exclusion criteria
Married women aged between 18 to 49 years; Exclusion of individuals with various diseases associated with sexual dysfunction; Exclusion of individuals taking medications known to affect sexual performance; Participants must have been diagnosed with Type 2 Diabetes for at least one year; Exclusion of individuals who have taken vitamin D supplements within the three months before the study; Participants must have normal levels of serum calcium, phosphorus, and albumin; Having insufficient vitamin D level
Intervention groups
Women of reproductive age who have type 2 diabetes and their vitamin D level is between 10_30 ng/ml. In the intervention group, Pearl has 50,000 units of vitamin D and in the control group, a placebo is administered weekly.
Main outcome variables
sexual function score; depression score; Vitamin D serum level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150624022896N3
Registration date: 2024-02-25, 1402/12/06
Registration timing: prospective

Last update: 2024-02-25, 1402/12/06
Update count: 0
Registration date
2024-02-25, 1402/12/06
Registrant information
Name
Maryam Kianpour
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3320 6595
Email address
kianpour@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vitamin D supplementation on the sexual function of women in reproductive age with type 2 diabetes in the vitamin D group compared to the placebo group
Public title
Investigating the effect of vitamin D on sexual function of women in reproductive age with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women between 18 to 49 years old Not suffering from a wide range of diseases that lead to sexual dysfunction Including: multiple sclerosis and any central nervous system disorders, mental disorders, mental retardation, vasculitis, uncontrolled hypo and hyperthyroidism, anatomical defects of the reproductive system, tumors and tumors and cancer Not taking drugs affecting sexual function Including: H2 receptor blockers, sleeping pills, cardiac and antihypertensive drugs, anticonvulsants, narcotic drugs, anticancer drugs and corticosteroids, antihistamines, opioids and alcohol and psychotropic drugs, barbiturates Gynecologic health and absence of endometriosis Absence of erectile disorders in the husband Minimum literacy level of the participants Self-reported absence of alcohol and smoking addiction by the women Awareness of place and time Satisfaction and willingness to participate in research suffering from Type 2 diabetes for at least one year Not taking vitamin D supplements at least three months before entering the study Have normal levels of serum Calcium, Phosphorus, and Albumin Body mass index (BMI) should be less than 30 Absence of malabsorption disorders Having insufficient vitamin D level (10 – 30 ng/ml)
Exclusion criteria:
Being pregnant or in the the firs trimester after delivery Surgical history of oophorectomy, hysterectomy, and mastectomy Early menopause (age less than 40 years)
Age
From 18 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 100 participants will randomly be divided into two groups that receive either medication (n=50) or a placebo (n=50) daily during the follow-up. Random allocation will be carried out using the permuted block randomization method with sizes of 2, 4, and 6. The random sequences will be generated by the “blockrand” package in R. The capsules (placebo/trial medication) will be allocated to participants via coded drug containers of identical appearance.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. After random grouping, the samples are divided into two control and intervention groups, the researcher and the samples do not know about this grouping, only the drug and placebo codes given to the people are recorded in their questionnaire.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave., Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2023-12-26, 1402/10/05
Ethics committee reference number
IR.MUI.MED.REC.1402.361

Health conditions studied

1

Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition

2

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Sexual function
Timepoint
Before the intervention and 13 weeks after the intervention
Method of measurement
Female Sexual Function Index Questionnaire (FSFI)

Secondary outcomes

1

Description
Vitamin D serum level
Timepoint
Before intervention
Method of measurement
HPLC kit (high performance liquid chromatography

2

Description
Depression score
Timepoint
Before intervention
Method of measurement
DASS21 questionnaire score

Intervention groups

1

Description
Intervention group: Weekly prescription of Pearl Vitamin D with a dose of 50,000 made by Tehran Daru Company for 12 weeks after lunch to increase drug absorption.
Category
Treatment - Drugs

2

Description
Control group: Weekly administration of vitamin D placebo made by Tehran Daru Company for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Dr Mansour Siavash Dastjerdi
Street address
Khoram Ave, Jomhouri Square, Isfahan, IRAN
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9933
Fax
+98 31 3337 3733
Email
emrc@mui.ac.ir
Web page address
https://emrc.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Maryam Kianpour
Street address
Hezar Jerib Ave,Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3669 9398
Email
webmaster@nm.mui.ac.ir
Web page address
https://mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Shakouri Jobani
Position
Midwifery MA student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Fax
Email
www.farimahshakori.75@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Kianpour
Position
َAssociate profesor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nursing and Midwifery Research Center- Nursing and Midwifery faculty- Isfahan University of Medical Sciences- Hezar gerib Ave - Isfahan
City
Isfahan
Province
Isfehan
Postal code
8138946497
Phone
+98 31 3792 7620
Email
kianpour@mail.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Kianpour
Position
َAssociate profesor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nursing and Midwifery Research Center- Nursing and Midwifery faculty- Isfahan University of Medical Sciences- Hezar gerib Ave - Isfahan
City
Isfahan
Province
Isfehan
Postal code
8138946497
Phone
+98 31 3792 7620
Email
kianpour@mail.mui.ac.ir

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
Undecided - It is not yet known if there will be 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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