The effect of vitamin D on quality of life and symptom severity of symptomatic uterine Leiomyoma in wome

Phase 3

• Conditions: terine leiomyoma.; Leiomyoma of uterus, unspecified; D25.9

• Registration Number: IRCT20160821029446N7
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 April 2020

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

Age between 15-49 years
At least existence of one confirmed uterine leiomyoma in the ultrasound without need of surgery
Existence of uterine leiomyoma symptoms in history
Under medical treatment of uterine leiomyoma
25 hydroxy vitamin D values less than 30 ng/ml

Exclusion Criteria

Pathology existence of the uterus, ovaries and adnexes in sonography
Existence of contraindication for vitamin D intake
Existence of any chronic medical condition
Pregnancy or desire to become pregnant within the next 6 months and lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: Before, 2 and 4 months after intervention. Method of measurement: Uterine Fibroid Symptom & Health-Related Quality Of Life Questionnaire.;Uterine Fibroid Symptom. Timepoint: Before, 2 and 4 months after intervention. Method of measurement: Uterine Fibroid Symptom & Health-Related Quality Of Life Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Serum concentration of 25-hydroxy vitamin D3. Timepoint: Before and 4 months after intervention. Method of measurement: Elisa test.