Status:
TERMINATED
L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia
Lead Sponsor:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Collaborating Sponsors:
University of Pennsylvania
Bill and Melinda Gates Foundation
Conditions:
Pre-Eclampsia
Eligibility:
FEMALE
19-32 years
Phase:
PHASE2
Brief Summary
This study is intended to assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population.
Detailed Description
Preeclampsia is a syndrome of unknown origin characterized by hypertension, edema and proteinuria. It usually appears in the third trimester and occurs most frequently in primigravidas. Preeclampsia m...
Eligibility Criteria
Inclusion
- Previous pregnancy complicated with pre-eclampsia/eclampsia
- Singleton pregnancy
- Gestational age \>20 weeks \<34 weeks
- Protein excretion \< 300 mg/day
Exclusion
- Multiple gestation
- Major fetal anomaly
- Pre-existing hypertension
- Pre-existing renal disease
- Diabetes
- Collagen vascular disease
- Cancer or strong family history of cancer in first degree relatives
- Preexisting maternal disease requiring medication
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
585 Patients enrolled
Trial Details
Trial ID
NCT00469846
Start Date
January 1 2001
End Date
November 1 2006
Last Update
May 8 2007
Active Locations (2)
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1
Univesity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6142
2
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Mexico City, D.F., Mexico, 11000