Muscle CrampNCT00516516
Oral Carnitine for Cramps in Pregnancy
A study testing L-Carnitine in people with Muscle Cramp, run by University of Southern California at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Muscle Cramp
- What is being tested?
- L-Carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
USC Perinatal Group Medical Office
Los Angeles, California, 90015
USC Perinatal Group Medical Office
Los Angeles, California, 90027
Women's & Children's Hospital Midwife Clinic
Los Angeles, California, 90033
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Cramp
- Being tested
- L-Carnitine, Placebo
- Keywords
- muscle cramp, pregnancy, carnitine, randomized controlled clinical trials
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDietary supplement
L-Carnitine, 1g orally, twice daily
PlaceboDietary supplement
Placebo, similar in appearance to study tablets, given orally, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Oral L-Carnitine, 1g PO twice daily Receives: Dietary Supplement: L-Carnitine |
| II | Placebo comparator | Placebo, similar in appearance to experimental drug, given orally twice daily. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete elimination of muscle cramps
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionJul 2009
Why it stopped: Low interest in study, slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle CrampStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Association
- Responsible party
- Sponsor
- Investigators
- Emiliano R Chavira, MD,MPH, Principal investigator, University of Southern California, Keck School of Medicine, Division of Maternal-Fetal MedicineThomas M Goodwin, MD, Principal investigator, University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516516
- Sponsor's protocol ID
- HS-06-00233
- Status last verified
- Oct 2009
- First submitted
- 14 Aug 2007
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00516516
- Acronym / sponsor ID
- HS-06-00233
- Conditions
- Muscle Cramp
- Keywords
- muscle cramp, pregnancy, carnitine, randomized controlled clinical trials
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low interest in study, slow recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Health Research Association
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Dietary Supplement: L-CarnitineOral L-Carnitine, 1g PO twice daily |
| II | Placebo comparator | Dietary Supplement: PlaceboPlacebo, similar in appearance to experimental drug, given orally twice daily. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CarnitineL-Carnitine, 1g orally, twice daily | Dietary supplement | I |
| PlaceboPlacebo, similar in appearance to study tablets, given orally, twice daily. | Dietary supplement | II |
Primary outcome
Complete elimination of muscle cramps
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Low interest in study, slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiliano R Chavira, MD,MPH principal investigator
University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
Thomas M Goodwin, MD principal investigator
University of Southern California, Keck School of Medicine, Division of Maternal-Fetal Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Carnitine in people with Muscle Cramp, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low interest in study, slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete elimination of muscle cramps (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.