Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Vitamin D receptor levels
研究概览
简要总结
This is a study performed to evaluate the role of vitamin D supplementation on the strength of levator ani muscle in menopausal women with pelvic organ prolapse
详细描述
Forty eight POP women were divided into experimental and control groups in this quasi-experimental study. The experimental group was given 0.5 mcg alfacalcidol orally for three months. We measured levator ani muscle strength, serum 25-hydroxy-vitamin D3 levels, and serum Vitamin D Receptor (VDR) levels at zero months and three months preoperative. Enzyme-linked immunosorbent assay (ELISA) assessed VDR and myoblast determination protein 1 (MyoD) protein expressions in levator ani muscle surgical biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients with pelvic organ prolapse stages III and IV who underwent surgery at menopausal age
- •normal BMI
- •initial serum vitamin D levels <30 ng/mL
排除标准
- •comorbidities (chronic cough, conspitation)
- •vitamin D metabolism or immune system interfering diseases or drugs specific routine medications such as anticonvulsants, statin, fibrate or orlistat
- •history of vitamin D supplementation within the last month
研究组 & 干预措施
Alfacalcidol
Alfacalcidol 0.5 mcg orally given for 3 months
干预措施: Alfacalcidol 0.0005 MG (Drug)
Control
Placebo given orally for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Vitamin D receptor levels
时间窗: 3 months
Vitamin D receptor levels as assessed by ELISA
Levator ani muscle strength
时间窗: 3 months
Levator ani muscle strength as measured using anometry
Vitamin D3 levels
时间窗: 3 months
Vitamin D3 levels measured using lab tests
次要结局
未报告次要终点