Study Stopped
Low interest in study, slow recruitment
Oral Carnitine for Cramps in Pregnancy
Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2007
CompletedFirst Posted
Study publicly available on registry
August 15, 2007
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedApril 20, 2017
October 1, 2009
11 months
August 14, 2007
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete elimination of muscle cramps
4 weeks
Study Arms (2)
I
EXPERIMENTALOral L-Carnitine, 1g PO twice daily
II
PLACEBO COMPARATORPlacebo, similar in appearance to experimental drug, given orally twice daily.
Interventions
Placebo, similar in appearance to study tablets, given orally, twice daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- Health Research Associationcollaborator
Study Sites (3)
USC Perinatal Group Medical Office
Los Angeles, California, 90015, United States
USC Perinatal Group Medical Office
Los Angeles, California, 90027, United States
Women's & Children's Hospital Midwife Clinic
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2007
First Posted
August 15, 2007
Study Start
July 1, 2008
Primary Completion
June 1, 2009
Study Completion
July 1, 2009
Last Updated
April 20, 2017
Record last verified: 2009-10