Muscle Cramp
Conditions
Keywords
muscle cramp, pregnancy, carnitine, randomized controlled clinical trials
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTL-Carnitine
L-Carnitine, 1g orally, twice daily
DIETARY_SUPPLEMENTPlacebo
Placebo, similar in appearance to study tablets, given orally, twice daily.
Sponsors
Health Research Association
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete elimination of muscle cramps | 4 weeks |
Countries
United States
Outcome results
None listed