Oral Carnitine for Cramps in Pregnancy

Not Applicable

Terminated

• Conditions: Muscle Cramp
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: L-Carnitine

• Registration Number: NCT00516516
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-15
• Study Start: 2008-07
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2009-10
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II	Placebo	Placebo, similar in appearance to experimental drug, given orally twice daily.
I	L-Carnitine	Oral L-Carnitine, 1g PO twice daily

Primary Outcome Measures

Name	Time	Method
Complete elimination of muscle cramps	4 weeks

Trial Locations

Locations (2)

USC Perinatal Group Medical Office; 🇺🇸 Los Angeles, California, United States

Women's & Children's Hospital Midwife Clinic; 🇺🇸 Los Angeles, California, United States