Oral Carnitine for Cramps in Pregnancy

April 18, 2017 updated by: University of Southern California

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90015
        • USC Perinatal Group Medical Office
      • Los Angeles, California, United States, 90027
        • USC Perinatal Group Medical Office
      • Los Angeles, California, United States, 90033
        • Women's & Children's Hospital Midwife Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Oral L-Carnitine, 1g PO twice daily
Dietary supplement: L-Carnitine
L-Carnitine, 1g orally, twice daily
Placebo Comparator: II
Placebo, similar in appearance to experimental drug, given orally twice daily.
Dietary supplement: Placebo
Placebo, similar in appearance to study tablets, given orally, twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete elimination of muscle cramps
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Health Research Association

Investigators

  • Principal Investigator: Emiliano R Chavira, MD,MPH, University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
  • Principal Investigator: Thomas M Goodwin, MD, University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-06-00233

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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