This study is a double blind randomized clinical trial to determine the effect of vitamin D administration compared with the placebo on sexual function in vitamin D-deficient women. 100 women, aged 18 to 45 years old with 25-(OH)D < 25 ng/ml, who were eligible for this study were recruited from selected healthcare centers in Tehran. Informed consent form was completed by each participant at the beginning of this single center study. Participants will be divided in two groups randomly. At first, both groups were educated about the normal sexual response. Participants in the intervention group, received two 300000IU vitamin D ampoules and in control group received two placebo contained with distilled water ampoules 4-week intervals. Depression grade at baseline and end of week 8 was evaluated by Beck questionnaire. At the beginning and end of week 8, serum 25(OH)-D3 was measured. Also, sexual function was assessed by FSFI questionnaire.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201608053860N28
Registration date:2016-11-06, 1395/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-06, 1395/08/16
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Nursing and Midwifery College, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-02-14, 1394/11/25
Expected recruitment end date
2016-08-19, 1395/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation compared with the placebo on changing of sexual function in vitamin D-deficient women
Public title
The effect of vitamin D on sexual function in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged 18 to 45 years old; 25(OH) D<30 ng/ml; Women must be without following diseases: hypothyroidism; hyperprolactinemia; liver diseases; and vaginal infection; Lack of stressful event during the past 6 months; Lack of mental problems; Without alcohol or drug addiction; Voluntary participitation.
Exclusion criteria: Taking any drug or supplement that interfere with sexual function; Getting pregnant; Migration.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization and Blinding: Participants will allocated randomly using a random number table; for this, a study leader who is not involve in study protocol will create the randomization list assigning participants to the vitamin D or the placebo group. Two vitamin D or placebo ampuls were provided for each participant and in order to two administration with 4-week interval. The study leader labeled these ampuls with participant numbers using the randomization list. Thus, none of investigator and participants had not any information about the type of groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Nursing and Midwifery College, Shahid Beheshti University of Medical Sciences
Street address
Valiasr St, Niayesh Junc
City
Tehran
Postal code
1985717443
Approval date
2016-03-01, 1394/12/11
Ethics committee reference number
IR.SBMU.PHNM.343.1394
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
dysfunction-sexual(due to)-lack-or loss of sexual desive
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention and then 4 and 8 weeks after the intervention
Method of measurement
FSFI questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Beck Depression questionnaire
Intervention groups
1
Description
Intervention group: Injection two 300000IU vitamin D ampoule; Iran Hormone; made in Iran; at baseline and end of week 4
Category
Treatment - Drugs
2
Description
Control group: Injection two water distilled ampoule ; Soha; made in Iran; at baseline and end of week 4
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasol Akram Hospital
Full name of responsible person
Fatemeh Jalali Chimeh
Street address
Mansori St, Niayesh Ave, Shahrara Ave, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Firozgar Hospital
Full name of responsible person
Fatemeh Jalali Chimeh
Street address
Behafarin St, Karimkhan Ave, Valiasr Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Nursing and Midwifery College, Shahid Beheshti University of Medical Sc
Full name of responsible person
Dr.Mahrokh Dolatian
Street address
Vice Chancellor of Research, Nursing and Midwifery College, Shahid Beheshti University of Medical Sciences, Valiasr St, Niayesh Junc
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Nursing and Midwifery College, Shahid Beheshti University of Medical Sc
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery College, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Jalali Chimeh
Position
Graduate Student Of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences, Valiasr St, Niayesh Junc, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 22523373
Fax
Email
fatemehjalali_ch@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery College, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
Assistant professor
Other areas of specialty/work
Street address
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences, Valiasr St, Niayesh Junc, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Fax
+98 21 2219 0684
Email
gozgoli@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)