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Oral Carnitine for Cramps in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University of Southern California.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Health Research Association
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00516516
First received: August 14, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

Muscle cramps occur frequently among pregnant women, and few therapeutic options exist. This is a study of oral L-carntine, 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 Phase
Muscle Cramp
 Dietary Supplement: L-Carnitine
Dietary Supplement: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Muscle Cramps
U.S. FDA Resources

Further study details as provided by University of Southern California:

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

Estimated Enrollment: 150
Study Start Date: August 2007
Estimated Study Completion Date: January 2008
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-carntine, 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
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516516

Contacts
Contact: Emiliano R Chavira, MD, MPH (626) 826-6456 echavira@usc.edu
Contact: Grace H Kong, MD (213) 919-5553 Grace.Kong@gmail.com

Locations
United States, California
Women's & Children's Hospital Midwife Clinic Not yet recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Emiliano R Chavira, MD, MPH            
USC Perinatal Group Medical Office Not yet recruiting
Los Angeles, California, United States, 90015
Principal Investigator: Emiliano R Chavira, MD, MPH            
USC Perinatal Group Medical Office Not yet recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Emiliano R Chavira, MD, MPH            
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: Grace H Kong, MD 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

No publications provided

ClinicalTrials.gov Identifier: NCT00516516     History of Changes
Other Study ID Numbers: HS-06-00233
Study First Received: August 14, 2007
Last Updated: August 14, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Muscle Cramp
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013