L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Procedure: L-arginine supplementation in a medical food
* Procedure: Vitamin C and E supplementation in a medical food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: L-arginine supplementation in a medical food|nan|
|Procedure: Vitamin C and E supplementation in a medical food|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of preeclampsia |  | During pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Eclampsia, Hypertension,pregnancy-induced, Preterm labor