Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.
研究概览
简要总结
39 women with symptomatic uterine fibroid with serum vitamin D deficiency will receive vitamin D3 supplementation for 6 month.then symptoms and size of fibroid will be re evaluated..
详细描述
Effects of vitamin D supplimentation on symptomatic uterine fibroid will be checked
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •.Women aged between 18-50 not currently pregnant, lactating, or planning to conceive during the study period.
- •Women with a confirmed diagnosis of uterine fibroids (leiomyoma) through ultrasound.
- •Serum 25-hydroxyvitamin D [25(OH)D] levels below 20 ng/mL (indicating vitamin D deficiency).
- •Presence of symptoms associated with uterine fibroid, such as menorrhagia (heavy menstrual bleeding), or bulk-related symptoms (e.g., urinary frequency).
- •Participants should be generally healthy, with no history of other chronic illnesses that could affect the study's outcomes (e.g., autoimmune diseases, cancers, severe liver or kidney diseases).
- •Willingness to provide written informed consent for participation in the study.
- •No current use of hormonal therapy, other vitamin D supplements, or medications known to influence calcium metabolism or uterine fibroid growth (e.g., GnRH agonists, anti-estrogens).
- •Participants must be willing and able to adhere to the study protocol, including attending follow-up visits and completing any required assessments or tests.
排除标准
- •Women younger than 18 or older than 50 years.
- •Serum 25-hydroxyvitamin D [25(OH)D] levels of 20 ng/mL or higher.
- •Women without a confirmed diagnosis of uterine fibroids (leiomyoma) through imaging.
- •Pregnant or breastfeeding women, or those planning to conceive during the study period.
- •Presence of chronic illnesses such as autoimmune diseases, cancers, or severe liver or kidney disease that could interfere with the study's outcomes.
- •Current or recent use of hormonal therapy, other vitamin D supplements, or medications that affect calcium metabolism or uterine fibroid growth (e.g., GnRH agonists, anti-estrogens).
- •Women who have undergone surgical interventions (e.g., myomectomy, hysterectomy) or other medical treatments specifically for uterine fibroid within the past 6 months.
- •Women with conditions like hyperparathyroidism or calcium disorders that might affect vitamin D metabolism or fibroid growth.
研究组 & 干预措施
Pt with uterine fibroid
Study subjects will be selected according to inclusion and exclusion criteria, consents will be taken in informed written consent form, and then preceded as follow- 39 diagnosed women with uterine fibroid aged 18 to 50 years experiencing heavy menstrual bleeding will be purposively selected upon meeting the selection criteria Demographic information, medical history, clinical examination findings, and other relevant clinical data will be gathered through interviews Baseline Assessments: menstrual blood loss, hemoglobin concentration and ultrasound parameters (uterine volume, fibroid characteristics) Participants received 25(OH) Vitamin D3 orally
干预措施: Colecalciferol (Vitamin D3) 50000 UI (Drug)
结局指标
主要结局
Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.
时间窗: 18 months
Fibroid size by cm
次要结局
未报告次要终点
研究者
Nahida Akter
Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh