Pharmacokinetics of Oral Calcium Carbonate in Parturients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ionized calcium concentration
研究概览
简要总结
This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "Tums"). Midway through the trial, with IRB permission, the oral calcium formulation was switched to calcium citrate to test whether this, better-absorbed formulation might prove more effective in increasing serum calcium. This information is important for trials investigating whether oral calcium can reduce postpartum hemorrhage, bleeding after delivery.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 单组
- 主要目的
- 其他
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- Pregnant female subjects at the study institution, admitted for labor (spontaneous, augmented, or induced)
排除标准
- severe range blood pressure (BP >160/>110) within the 48 hours prior to delivery
- patient age <18 years or >45 years
- renal dysfunction with a documented serum Cr > 1.0 mg/dL
- known history of congenital or acquired cardiac disease or history of arrhythmia
- patient taking digoxin
- patient currently taking a calcium channel blocker
- Weight <55kg or >100kg, or
- receiving magnesium infusion within 24 hours prior to or during cesarean delivery
- Prior or planned administration of calcium by the obstetric or anesthesiology teams for clinical indications within 24 hours of study enrollment
- Patient took a calcium supplement in the past 48 hours
- Patient status is NPO (nothing by mouth) as ordered by the clinical team
研究组 & 干预措施
Oral calcium citrate
Participants receive a single oral dose of calcium citrate 1250mg
干预措施: Oral calcium citrate (Drug)
Oral calcium carbonate
Patients take a single dose of oral calcium carbonate 1200mg
干预措施: Oral calcium carbonate (Drug)
结局指标
主要结局
Ionized calcium concentration
时间窗: 4 hours
Ionized calcium (mmol/L) is measured at baseline and over 5 additional convenience timepoints over the 4 hours after ingestion of calcium carbonate 3000mg.
次要结局
未报告次要终点
研究者
Jessica Ansari, MD, MS
Principal Investigator
Stanford University
研究点 (1)
标识符
- NCT 编号
- NCT06650930
- 其他研究编号
- 77182
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (11个月前)
- 研究完成日期
- (10个月前)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Patient privacy