Oral Carnitine for Cramps in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Muscle Cramp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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I

Oral L-Carnitine, 1g PO twice daily

Group Type EXPERIMENTAL

L-Carnitine

Intervention Type DIETARY_SUPPLEMENT

L-Carnitine, 1g orally, twice daily

II

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo, similar in appearance to study tablets, given orally, twice daily.

Interventions

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L-Carnitine

L-Carnitine, 1g orally, twice daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo, similar in appearance to study tablets, given orally, twice daily.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No