Oral Carnitine for Cramps in Pregnancy
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 14, 2007 | ||||||||||||
| Last Updated Date | August 14, 2007 | ||||||||||||
| Start Date ICMJE | August 2007 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Complete elimination of muscle cramps [ Time Frame: 4 weeks ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Oral Carnitine for Cramps in Pregnancy | ||||||||||||
| Official Title ICMJE | Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial | ||||||||||||
| Brief Summary | 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. |
||||||||||||
| 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. |
||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 2 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||||||
| Condition ICMJE | Muscle Cramp | ||||||||||||
| Intervention ICMJE |
|
||||||||||||
| Study Arm (s) |
|
||||||||||||
| Publications * | Not Provided | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||||||
| Estimated Completion Date | January 2008 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Gender | Female | ||||||||||||
| Ages | 16 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
|
||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00516516 | ||||||||||||
| Other Study ID Numbers ICMJE | HS-06-00233 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | University of Southern California | ||||||||||||
| Collaborators ICMJE | Health Research Association | ||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | University of Southern California | ||||||||||||
| Verification Date | August 2007 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||