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IRCT2014121511019N4 IRCT 2015-02-24 Vice Chancellor for Research and Technology, Semnan University of Medical Sciences Vitamin D or placebo in treatment of uterine leiomyoma Assessment of Vitamin D effect in compare to placebo in decreasing of leiomyoma size in patients with uterine leiomyoma 2015-01-21 anticipated 40 Complete https://irct.ir/trial/11380 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Study designed as double-blind clinical trial, so that the investigator and the patient do not know about what they received (drug or placebo). Be the first person in the intervention or the control group specified by tossing up and the rest assigned as every other. 2-3 Volume and duration of mensturation, Leiomyoma of uterus, size. Intervention 1: The patients in case group will receive vitamin D pearl (brand name: Vitin-D 50000IU, manufactured by Zahravi pharmaceutical company, Iran)one per week for eight weeks, after which if the levels of vitamin D was normal, vitamin D continued one pearl per month and if the levels of vitamin D was low vitamin D continued one pearl per week for 4 weeks. Intervention 2: Patients in control group will receive placebo pearl (manufactured by Zahravi pharmaceutical company, Iran) in similar route to intervention group for 8 weeks and followed without any additional interventions.
public Dr. Mahboobeh Saghafi
Imam Hussein Square
Semnan Iran (Islamic Republic of) +98 23 3344 0066 saghafimah@yahoo.com Semnan University of Medical Sciences scientific Dr. Mojgan Rahmanian
Imam Hussein Square
Semnan Iran (Islamic Republic of) +98 23 3346 0066 Rahmanian_74@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age between 20 and 45 years, having one or more uterine fibroids, the largest be 3 cm based on ultrasound, vitamin D and 25-hydroxyvitamin D concentrations lower than 75 nmol per liter or 30 ng/ml. Exclusion criteria: Leiomyoma with acute symptoms which requiring to immediate surgical intervention, liver or kidney disorders, cancer of the uterus, cervix and ovarian, adnexal mass, endometrial lesions such as polyps on ultrasound, use of hormonal therapy in the last three months, pregnancy, lactation or the desire to become pregnant during the study period, delivery within the last six months, uterine myoma in size more than 12 cm, the size of the uterine leiomyoma more than 20 weeks, history of gastrointestinal problems, especially malabsorption syndrome. 20 years 45 years Female N92.0, N92 Irregular menstruation, Leiomyoma of uterus, unspecified, Excessive and frequent mensturation with regular or irregular cycle Treatment - Drugs Placebo The patients in case group will receive vitamin D pearl (brand name: Vitin-D 50000IU, manufactured by Zahravi pharmaceutical company, Iran)one per week for eight weeks, after which if the levels of vitamin D was normal, vitamin D continued one pearl per month and if the levels of vitamin D was low vitamin D continued one pearl per week for 4 weeks. Patients in control group will receive placebo pearl (manufactured by Zahravi pharmaceutical company, Iran) in similar route to intervention group for 8 weeks and followed without any additional interventions. Size of Uterine Liomyoma. Timepoint: 4 months after intervention. Method of measurement: Sonography study. Menstrual bleeding and related symptoms. Timepoint: 2, 3 and 4 months after intervention. Method of measurement: Pictorial Blood Loss Assessment Chart (PBAC) and Visual analog scale (VAS). Vice Chancellor for Research and Technology, Semnan University of Medical Sciences Approved 2014-12-22 Ethical Committee of Semnan University of Medical Sciences Basidj Boulevard, Semnan University of medical Sciences Semnan Iran (Islamic Republic of)