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

Clinical trial to evaluate the effect of vitamin D supplements on menstrual pattern, levels of Sexual hormones and sexual function in women with multiple sclerosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016061528449N4
Enrollment
68
Registered
2016-08-29
Start date
2016-08-22
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: In the intervention group using transparent pills of 25 hydroxy vitamin D 3. Intervention 2: In the control group using placebo.

Sponsors

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

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin zarabadipour

Iran University of Medical Sciences

zarabadipours@yahoo.com+98 28 3367 5101

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026