Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Complete elimination of muscle cramps
研究概览
简要总结
Muscle cramps occur frequently among pregnant women, and few therapeutic options exist. This is a study of oral L-carnitine, a dietary supplement, for the treatment of muscle cramps in pregnancy. Our hypothesis is that carnitine will alleviate or eliminate muscle cramps experienced by pregnant women.
详细描述
Muscle cramps occur frequently among pregnant women, and few therapeutic options exist. This is a study of oral L-carnitine, a dietary supplement, for the treatment of muscle cramps in pregnancy. The conceptual basis for this study comes from the fact that carnitine has been used effectively in multiple randomized trials for the treatment of muscle cramps in other carnitine deficient states (such as hemodialysis). In pregnancy, women have decreased serum carnitine concentrations (from decreased intake, increased clearance by the kidney, and increased demands from the fetus). Thus, our hypothesis is that carnitine will alleviate or eliminate muscle cramps experienced by pregnant women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 16 or older
- •Gestational Age 12 to 33 weeks
- •Occurrence of muscle cramps at least once weekly
- •Ability to tolerate oral L-Carnitine
- •Ability / willingness to provide informed consent in English or Spanish
排除标准
- •Prior treatment for muscle cramps during this pregnancy
- •Chronic muscle cramps prior to pregnancy
- •Magnesium administration beyond that contained in prenatal vitamins
- •History of seizures
- •History of Pre-term delivery before 36 weeks gestational age
- •Inability to tolerate oral L-Carnitine (e.g. hyperemesis gravidarum)
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
Complete elimination of muscle cramps
时间窗: 4 weeks
次要结局
未报告次要终点
