L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia

Phase 2

Terminated

• Conditions: Pre-Eclampsia

• Registration Number: NCT00469846
• Lead Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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 may be complicated by life-threatening conditions including seizures, severe hepatic dysfunction, renal failure and coagulopathy; it is one of the leading causes of maternal morbidity and mortality worldwide. Preeclampsia is cited as the leading cause of maternal death in surveys of maternal mortality in Mexico (25% of maternal deaths).

Specific Aim 1. 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. Two other groups will receive the food (bars) either with antioxidant vitamins alone or without vitamins in order to test the impact of vitamin supplements on prevention of preeclampsia. The primary hypothesis to be tested is that supplemental L-arginine in combination with antioxidant vitamins will significantly reduce preeclampsia (hypertension and proteinuria) and its complications in a high-risk population (women whose blood pressure is \> 140/90 after 20 weeks gestation without proteinuria). Secondary hypotheses to be tested include that antioxidant vitamin supplementation contributes to the reduction in preeclampsia; that supplemental L-arginine and antioxidant vitamins will improve neonatal outcomes (reduced incidence of prematurity and intrauterine growth retardation); that preeclampsia is correlated inversely with plasma L-arginine levels, directly with the plasma levels of the endogenous NO synthase inhibitor, asymmetric dimethyl arginine (ADMA), and inversely with urinary NO metabolites, a marker of endogenous NO production; and that preeclampsia is inversely correlated with maternal plasma levels of antioxidant vitamins.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2006-11
• Status Verified: 2007-04
• Study First Submitted: 2007-05-04
• Study First Submitted QC: 2007-05-04
• Study First Posted: 2007-05-07
• Last Update Submitted: 2007-05-07
• Last Update Posted: 2007-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 585

Inclusion Criteria

• Previous pregnancy complicated with pre-eclampsia/eclampsia
• Singleton pregnancy
• Gestational age >20 weeks <34 weeks
• Protein excretion < 300 mg/day

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Development of preeclampsia	During pregnancy

Secondary Outcome Measures

Name	Time	Method
Development of eclampsia	During pregnancy
Occurrence of HELP syndrome	During pregnancy
Occurrence of preterm labor, preterm premature rupture of the membranes	During pregnancy
Gestational age at delivery	End of pregnancy

Trial Locations

Locations (2)

Univesity of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes; 🇲🇽 Mexico City, D.f., Mexico