NCT05151393Unknown不适用
Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
研究概览
简要总结
The aim of the current study is to evaluate the association between low serum vitamin D level and incidence of uterine leiomyoma in Egyptian women as the research hypothesis that low serum vitamin D is considered a risk factor for uterine leiomyoma
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ranging from 20 to 45 years.
- •Postmenstrual patients to exclude current pregnancy.
- •Parity up to para 3 by either normal vaginal delivery or cesarean section.
- •Body mass index (BMI) ranging from 18 to 30 kg/m
- •One or more uterine fibroid with a diameter ranging from 3-10 cm.
- •Fibroids either subserous, intramural or submucous uterine fibroids
排除标准
- •Women aged less than 20 years have a very low incidence of fibroids or more than 45 years as there is an increased incidence of vitamin D deficiency after this age.
- •Patients known to be currently pregnant due to change in fibroids volume during pregnancy in addition to vitamin D levels may be lower than baseline for nonpregnant ones.
- •Grand multipara >3 times frequently associated with vitamin D deficiency.
- •Cardiac( e.g rheumatic heart diseases), pulmonary( e.g asthma, bronchiectasis ), or hematological disease (including anemia; hemoglobin level below 10gm/dl , thalassemia, sickle cell anemia, and spherocytosis) because of high association between chronic illnesses and multivitamin deficiency.
- •Patients who receive pre-operative hormonal therapy (such as GnRH analogue) which may increase vitamin D levels and interfere with the study objectives.
- •Patients who will present with a suspected malignant gynecological disease which is usually associated with multiple vitamin deficiencies including vitamin D.
- •Patients who will be diagnosed as having cervical or supracervical fibroids and pedunculated fibroids (study will be limited on corporeal fibroid).
- •Small fibroid less than 3cm diameter may not be enough size to cause changes in lab results or large ones more than 10 cm diameter.
- •Previous myomectomy or hysterectomy.
- •Using vitamin supplements or hormonal therapy during or within 6 months of enrolment which may interfere with the accurate results of the study.
- •Current lactating or lactating within 6 months prior to enrollment as breastfeeding women have a significantly higher prevalence of vitamin D deficiency.
- •Current smokers or history of smoking as it decreases the production of the active form of vitamin D.
- •Steroids intake as it increases the 24-hydroxylase level causing vitamin D deficiency.
- •Cases diagnosed with any form of malignancy that may be associated with vitamin D deficiency.
- •Current treatment with heparin as it interferes with vitamin D activation.
- •Patients currently on depo-medroxyprogesterone-acetate (DMPA) contraceptives as it proved benefits in shrinking fibroid size.
结局指标
主要结局
Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
时间窗: 6 months
Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
次要结局
- Correlation of low serum vitamin D with size, site and number of fibroids(6 months)
- Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).(6 months)
- Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma(6 months)
研究者
Mohamed Samy
Obs/Gyn resident
Ain Shams University
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