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临床试验/NCT00516516
NCT00516516终止不适用

Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial

University of Southern California5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年7月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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