Effect of vitamin D pills on Menstrual pattern, levels of Sexual hormones and Sexual function in women with Multiple sclerosis

Phase 3

Conditions: Multiple sclerosis.
Multiple sclerosis

Registration Number: IRCT2016061528449N4

Lead Sponsor: Vice chancellor for research, Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 68

Inclusion Criteria

Married women between 20 and 40 years of age;
Confirmation on diagnosis with MS by neurologist during the past year and Having the same therapeutic regimen
No acute or chronic disease other than multiple sclerosis
No record of disease associated with vitamin D malabsorption (constipation, diarrhea, celiac sprue, short bowel syndrome, and cystic fibrosis)
No suffering the husband of chronic diseases and mental illness
A minimum of one sexual intercourse in a month
The vitamin D serum level of lower than 50 (ng/mL)
No record of vitamin D supplementations There is no special diet and be omnivorous
The expanded disability status score of lower than 4
no exposure to the severe crisis since the death of someone close to 3 months
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

Exclusion Criteria

reluctant to continue the study
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 regular consumption of vitamin D and avoiding the use of more than one dose during the study;
Appearing serious complications that require neurological intervention

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Levels of Sexual hormones. Timepoint: Patients are tested twice for Levels of Sexualhormones(Estrogen andTestosterone)(One day before the first day of training–one day after the final day training course). Method of measurement: Blood sampling.

Secondary Outcome Measures

Name	Time	Method
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.;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.