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Low interest in study, slow recruitment
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| Name | Class |
|---|---|
| Health Research Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Oral L-Carnitine, 1g PO twice daily |
|
| II | Placebo Comparator | Placebo, similar in appearance to experimental drug, given orally twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Carnitine | Dietary Supplement | L-Carnitine, 1g orally, twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete elimination of muscle cramps | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Perinatal Group Medical Office | Los Angeles | California | 90015 | United States | ||
| USC Perinatal Group Medical Office |
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| ID | Term |
|---|---|
| D009120 | Muscle Cramp |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo |
| Dietary Supplement |
Placebo, similar in appearance to study tablets, given orally, twice daily. |
|
| Los Angeles |
| California |
| 90027 |
| United States |
| Women's & Children's Hospital Midwife Clinic | Los Angeles | California | 90033 | United States |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |