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

August 14, 2007
August 14, 2007
August 2007
Not Provided
Complete elimination of muscle cramps [ Time Frame: 4 weeks ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Oral Carnitine for Cramps in Pregnancy
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-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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Muscle Cramp
  • Dietary Supplement: L-Carnitine
    L-Carnitine, 1g orally, twice daily
  • Dietary Supplement: Placebo
    Placebo, similar in appearance to study tablets, given orally, twice daily.
  • Experimental: I
    Oral L-Carnitine, 1g PO twice daily
    Intervention: Dietary Supplement: L-Carnitine
  • Placebo Comparator: II
    Placebo, similar in appearance to experimental drug, given orally twice daily.
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
January 2008
Not Provided

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
Female
16 Years and older
No
Contact: Emiliano R Chavira, MD, MPH (626) 826-6456 echavira@usc.edu
Contact: Grace H Kong, MD (213) 919-5553 Grace.Kong@gmail.com
United States
 
NCT00516516
HS-06-00233
Yes
Not Provided
University of Southern California
Health Research Association
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
University of Southern California
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP