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Oral Carnitine for Cramps in Pregnancy

Primary Purpose

Muscle Cramp

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-Carnitine
Placebo
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Cramp focused on measuring muscle cramp, pregnancy, carnitine, randomized controlled clinical trials

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • USC Perinatal Group Medical Office
  • USC Perinatal Group Medical Office
  • Women's & Children's Hospital Midwife Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

I

II

Arm Description

Oral L-Carnitine, 1g PO twice daily

Placebo, similar in appearance to experimental drug, given orally twice daily.

Outcomes

Primary Outcome Measures

Complete elimination of muscle cramps

Secondary Outcome Measures

Full Information

First Posted
August 14, 2007
Last Updated
April 18, 2017
Sponsor
University of Southern California
Collaborators
Health Research Association
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1. Study Identification

Unique Protocol Identification Number
NCT00516516
Brief Title
Oral Carnitine for Cramps in Pregnancy
Official Title
Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
Low interest in study, slow recruitment
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
Health Research Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Cramp
Keywords
muscle cramp, pregnancy, carnitine, randomized controlled clinical trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Oral L-Carnitine, 1g PO twice daily
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
Placebo, similar in appearance to experimental drug, given orally twice daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Carnitine
Intervention Description
L-Carnitine, 1g orally, twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo, similar in appearance to study tablets, given orally, twice daily.
Primary Outcome Measure Information:
Title
Complete elimination of muscle cramps
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano R Chavira, MD,MPH
Organizational Affiliation
University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas M Goodwin, MD
Organizational Affiliation
University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Perinatal Group Medical Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
USC Perinatal Group Medical Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Women's & Children's Hospital Midwife Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Oral Carnitine for Cramps in Pregnancy

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