Oral Carnitine for Cramps in Pregnancy

Muscle Cramp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00516516
• Other study ID #: HS-06-00233
• Status: Terminated
• Phase: N/A
• First received: August 14, 2007
• Last updated: April 18, 2017
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Cramp
• Spasm

Intervention

Dietary Supplement:
• L-Carnitine
L-Carnitine, 1g orally, twice daily
• Placebo
Placebo, similar in appearance to study tablets, given orally, twice daily.

Locations

Country	Name	City	State
United States	USC Perinatal Group Medical Office	Los Angeles	California
United States	USC Perinatal Group Medical Office	Los Angeles	California
United States	Women's & Children's Hospital Midwife Clinic	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Health Research Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete elimination of muscle cramps		4 weeks