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Oral Carnitine for Cramps in Pregnancy

This study has been terminated.
(Low interest in study, slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516516
First Posted: August 15, 2007
Last Update Posted: April 20, 2017
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.
Collaborator:
Health Research Association
Information provided by (Responsible Party):
University of Southern California
August 14, 2007
August 15, 2007
April 20, 2017
July 2008
June 2009   (Final data collection date for primary outcome measure)
Complete elimination of muscle cramps [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00516516 on ClinicalTrials.gov Archive Site
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-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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Terminated
30
July 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00516516
HS-06-00233
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
University of Southern California
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: Thomas M Goodwin, MD University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
University of Southern California
October 2009

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