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Vitamin D or placebo in treatment of uterine leiomyoma

Phase 2
Conditions
Volume and duration of mensturation, Leiomyoma of uterus, size.
Irregular menstruation, Leiomyoma of uterus, unspecified, Excessive and frequent mensturation with regular or irregular cycle
N92.0, N92
Registration Number
IRCT2014121511019N4
Lead Sponsor
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
40
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.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Size of Uterine Liomyoma. Timepoint: 4 months after intervention. Method of measurement: Sonography study.
Secondary Outcome Measures
NameTimeMethod
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).
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