ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Carnitine for Cramps in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00516516
Recruitment Status : Terminated (Low interest in study, slow recruitment)
First Posted : August 15, 2007
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Health Research Association
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Muscle Cramp Dietary Supplement: L-Carnitine Dietary Supplement: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial
Study Start Date : July 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

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.




Primary Outcome Measures :
  1. Complete elimination of muscle cramps [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516516


Locations
United States, California
USC Perinatal Group Medical Office
Los Angeles, California, United States, 90015
USC Perinatal Group Medical Office
Los Angeles, California, United States, 90027
Women's & Children's Hospital Midwife Clinic
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
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

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00516516     History of Changes
Other Study ID Numbers: HS-06-00233
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: October 2009

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Southern California:
muscle cramp
pregnancy
carnitine
randomized controlled clinical trials

Additional relevant MeSH terms:
Muscle Cramp
Spasm
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms