Oral Carnitine for Cramps in Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral L-Carnitine for the Treatment of Muscle Cramps in Pregnancy: A Randomized, Controlled Trial

Conditions
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Muscle Cramp

Intervention / Treatment
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* Dietary Supplement: L-Carnitine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Oral L-Carnitine, 1g PO twice daily | Dietary Supplement: L-Carnitine<br>* L-Carnitine, 1g orally, twice daily<br>|
| Placebo Comparator: II<br>Placebo, similar in appearance to experimental drug, given orally twice daily. | Dietary Supplement: Placebo<br>* Placebo, similar in appearance to study tablets, given orally, twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete elimination of muscle cramps |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle cramp, pregnancy, carnitine, randomized controlled clinical trials