Clinical trial to evaluate the effect of vitamin D pills on menstrual pattern, levels of steroid hormones and sexual function in women with multiple sclerosis
(1) Aim: The aim of this study is the Effects of vitamin D pills on Menstrual pattern, levels of Steroid hormones and Sexual function in women with Multiple sclerosis. (2) Design: The participation will divided to 2 groups (use of vitamin D) and control (placebo ). (3) Method: In this quasi-experimental study 94 persons with Multiple sclerosis will take part. (4) Inclusion criteria for the study: Age 40-20 years; Having the same therapeutic regimen; Passing at least a year of diagnosis; No acute or chronic disease other than multiple sclerosis; No constipation and diarrhea or other gastrointestinal diseases; No exposure to the severe crisis since the death of someone close to 3 months; No suffering the husband of chronic diseases and mental illness; Not using hormonal contraception at least in the last 3 months; No pregnancy and lactation and does not plan to become pregnant in the last 3 months; Serum vitamin D levels less than nmol / L 50; There is no special diet and be omnivorous; EDSS score be less than 4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061528449N4
Registration date:2016-08-29, 1395/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-08-29, 1395/06/08
Registrant information
Name
simin zarabadipour
Name of organization / entity
Iran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 218670250300
Email address
zarabadipoor.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the effect of vitamin D pills on menstrual pattern, levels of steroid hormones and sexual function in women with multiple sclerosis
Public title
Effect of vitamin D pills on Menstrual pattern, levels of Steroid hormones and Sexual function in women with Multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for the study: Age 40-20 years; Having the same therapeutic regimen; Passing at least a year of diagnosis; No acute or chronic disease other than multiple sclerosis; No constipation and diarrhea or other gastrointestinal diseases; No exposure to the severe crisis since the death of someone close to 3 months; No suffering the husband of chronic diseases and mental illness; Not using hormonal contraception at least in the last 3 months; No pregnancy and lactation and does not plan to become pregnant in the last 3 months; Serum vitamin D levels less than nmol / L 50; There is no special diet and be omnivorous; EDSS score be less than 4. Exclusion criteria: Aggravation of the disease during the study; Accurring of pregnancy during the study; Facing a critical factor causing such death of a family member or hospitalization in the last 3 months; No using of regular consumption of vitamin D and avoiding the use of more than one dose during the study; Appearing serious complications that require neurological intervention.
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Medical Sciences Iran, school of Nursing and Midwifery
Street address
Yasemi Rashid Street, valiasr street, tehran School of Nursing and Midwifery
City
Tehran
Postal code
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
IR.IUMS.REC. 1395.9311373017
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Serum levels of 25 hydroxy vitamin D3
Timepoint
The patients' serum 25 hydroxy vitamin D3 levels measured twice ( once before and once after the last day of the intervention)
Method of measurement
Blood sampling
2
Description
Levels of steroid hormones
Timepoint
Patients are tested twice for Levels of steroid hormones(One day before the first day of training–one day after the final day training course).
Method of measurement
Blood sampling
Secondary outcomes
1
Description
Menstrual pattern
Timepoint
Patients are tested twice for Menstrual pattern. (One day before the first day of training–one day after the final day training course).
Method of measurement
questionnaire
2
Description
Sexual function
Timepoint
Patients are tested twice for Sexual function . (One day before the first day of training–one day after the final day training course).
Method of measurement
questionnaire
Intervention groups
1
Description
In the intervention group using transparent pills of 25 hydroxy vitamin D 3
Category
Placebo
2
Description
In the control group using placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomeini hospital neurology clinic
Full name of responsible person
Simin zarabadipour
Street address
The street Italy, Palestine Avenue, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Sinai Hospital Neurology Clinic
Full name of responsible person
Simin zarabadipour
Street address
Imam Khomeini street,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
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 for research, Iran University of Medical Sciences