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L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia

Supplementation With L-Arginine and Antioxidant Vitamins During Pregnancy in a Medical Food to Reduce the Risk of Preeclampsia in a High Risk Population

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00469846
Acronym
L-Arg
Enrollment
585
Registered
2007-05-07
Start date
2001-01-31
Completion date
2006-11-30
Last updated
2007-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia, Hypertension,pregnancy-induced, Preterm labor

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.

Interventions

PROCEDUREL-arginine supplementation in a medical food
PROCEDUREVitamin C and E supplementation in a medical food

Sponsors

University of Pennsylvania
CollaboratorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 32 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Development of preeclampsiaDuring pregnancy

Secondary

MeasureTime frame
Development of eclampsiaDuring pregnancy
Occurrence of HELP syndromeDuring pregnancy
Occurrence of preterm labor, preterm premature rupture of the membranesDuring pregnancy
Gestational age at deliveryEnd of pregnancy

Countries

Mexico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026