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IRCT2016061528449N4 IRCT 2016-08-29 Vice chancellor for research, Iran University of Medical Sciences 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 2016-08-22 anticipated 68 Complete https://irct.ir/trial/23091 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible Participants were consecutively recruited and randomly allocated to an intervention and a control group. For randomization, a table of random numbers from 1 to 200 was generated and then, each new patient recruited to the study was asked to randomly select a number between 1 and 200. She would be allocated to the intervention group if she selected a three-digit odd number, while she would be allocated to the control group if she selected a two-digit even number. Then, selected numbers were removed from the table. If the patient selected any other numbers, she would be asked to select another number until she can pick out either a three-digit odd number or a two-digit even number, Blinding description: This was a double-blind study in which neither participants nor statistical analyst was aware of the group allocation. For blinding, participants were not provided with information about the packet content of the tablets. Moreover, they were visited individually and were unaware of the tablets provided to other participants. Vitamin D and placebo tablets used in this study were produced by Zahravi Pharmaceutical Company, Tabriz, Iran. Placebo tablets contain edible paraffin. 3 Multiple sclerosis. Intervention 1: In the intervention group using transparent pills of 25 hydroxy vitamin D 3. Intervention 2: In the control group using placebo. Yes - There is a plan to make this available What will be shared: If there is a need to conduct secondary studies or other researchers need the data, the data file, which has been anonymized and includes all the variables measured in this research, will be provided. When: One year after the results are published To whom: Data for all academic researchers or industrial research centers Conditions: If there is a need to do additional studies or secondary studies Where to obtain: If you need to receive data, contact Ms. Zarabadipour :00989127837998 How to obtain: Provide the reason for the request and the person or institution that needs this data Comments:
public Simin zarabadipour
Tehran, pasdaran Street, rastvan Street
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 28 3367 5101 zarabadipours@yahoo.com Iran University of Medical Sciences scientific Leila Amini
School of Nursing and Midwifery, Yasemi Rashid Street,Valiasr Street, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 214365181500 Amini.L@iums.ac.ir University of Medical Sciences Iran, school of Nursing and Midwifery Iran (Islamic Republic of) 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 20 years 40 years Female 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 G35 Multiple sclerosis Placebo Placebo In the intervention group using transparent pills of 25 hydroxy vitamin D 3 In the control group using placebo 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. 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. Vice chancellor for research, Iran University of Medical Sciences Approved 2016-05-28 University of Medical Sciences Iran, school of Nursing and Midwifery Yasemi Rashid Street, valiasr street, tehran School of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)