Oral Carnitine for Cramps in Pregnancy
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Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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