Oral Carnitine for Cramps in Pregnancy

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine.

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.

Their hypothesis is that carnitine will alleviate or eliminate muscle cramps experienced by pregnant women.

It had two arms (groups): I (experimental) and II (placebo comparator).

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

The registry classes the interventions as dietary supplement.

More on the Plan

Thus, their hypothesis is that carnitine will alleviate or eliminate muscle cramps experienced by pregnant women.

Who Took Part

The registry lists 30 actual participants took part.

It was open to women only aged from 16 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: prior treatment for muscle cramps during this pregnancy; chronic muscle cramps prior to pregnancy; magnesium administration beyond that contained in prenatal vitamins.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-07 with completion listed for 2009-06.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Complete elimination of muscle cramps (time frame: 4 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 30 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.