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Oral Carnitine for Cramps in Pregnancy

This study has been terminated.
(Low interest in study, slow recruitment)
Sponsor:
Collaborator:
Health Research Association
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00516516
First received: August 14, 2007
Last updated: April 18, 2017
Last verified: October 2009
  Purpose
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 Intervention
Muscle Cramp
Dietary Supplement: L-Carnitine
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

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

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00516516     History of Changes
Other Study ID Numbers: HS-06-00233
Study First Received: August 14, 2007
Last Updated: April 18, 2017

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

ClinicalTrials.gov processed this record on April 24, 2017