Clinical trial NCT00516516: Oral Carnitine for Cramps in Pregnancy
Official title: Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Muscle Cramp
Keywords: muscle cramp
pregnancy
carnitine
randomized controlled clinical trials
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Health Research Association
First posted: 2007-08-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete elimination of muscle cramps
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Perinatal Group Medical Office
state: California
city: Los Angeles
country: United States
facility: USC Perinatal Group Medical Office
state: California
city: Los Angeles
country: United States
facility: Women's & Children's Hospital Midwife Clinic
state: California
Study officials:
affiliation: University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
name: Emiliano R Chavira, MD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
name: Thomas M Goodwin, MD
role: PRINCIPAL_INVESTIGATOR
References: