fibrom. Leiomyoma of uterus, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1- Confirmation of the presence of at least one fibroid measuring 20-80 mm on abdominal or vaginal ultrasound by a radiologist Serum vitamin D level of 20-30 ng/ml
Exclusion criteria
Exclusion criteria: History of hormonal medication use uterine fibroid treatment in the past 3 months history of vitamin D supplementation in the past 6 months severe vaginal bleeding adenomyosis evidence of malignancy menopause metabolic diseases lack of follow-up visits sensitivity to vitamin D desire to become pregnant inability to follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fibroid size. Timepoint: Before the start of the intervention and after 4 and 8 weeks from the start of the intervention. Method of measurement: Ultrasound and testing.;Number of fibroids. Timepoint: Before the start of the intervention and after 12 months from the start of the intervention. Method of measurement: Ultrasound.;Hemoglobin level. Timepoint: Beginning of the intervention and end of the intervention. Method of measurement: Test.;Vitamin D3 levels. Timepoint: Beginning of the intervention and end of the intervention. Method of measurement: test.;Age. Timepoint: Beginning of the intervention. Method of measurement: Hospital Information System.;Pelvic pain (dysmenorrhea, menorrhagia). Timepoint: Beginning of the intervention and end of the intervention. Method of measurement: Clinical examination.;Urinary symptoms. Timepoint: Beginning of the intervention and end of the intervention. Method of measurement: Clinical examination.;BMI. Timepoint: Beginning of the intervention. Method of measurement: Scales and meters.;Location of fibroids. Timepoint: Beginning of the intervention and end of the intervention. Method of measurement: Ultrasound.;Age of onset of menarche. Timepoint: Beginning of the intervention. Method of measurement: Question.;Side effects of vitamin D. Timepoint: Start of intervention, 4 and 8 weeks after intervention, and at the end of the study. Method of measurement: Clinical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibroid size. Timepoint: First and last reading. Method of measurement: Ultrasound.;Number of fibroids. Timepoint: First and last reading. Method of measurement: Ultrasound.;Hemoglobin level. Timepoint: First and last reading. Method of measurement: test.;Vitamin D3 levels. Timepoint: First and last reading. Method of measurement: TEST. | — |
Countries
Iran (Islamic Republic of)
Contacts
Qazvin University of Medical Sciences