L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia

Pre-Eclampsia Clinical Trial

— L-Arg  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00469846
• Other study ID #: 212250-02071
• Status: Terminated
• Phase: Phase 2
• First received: May 4, 2007
• Last updated: May 7, 2007
• Start date: January 2001
• Est. completion date: November 2006

Study information

• Verified date: April 2007
• Source: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentMexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 585
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 32 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Procedure:
• L-arginine supplementation in a medical food

• Vitamin C and E supplementation in a medical food

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes	Mexico City	D.f.
United States	Univesity of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes	Bill and Melinda Gates Foundation, University of Pennsylvania

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of preeclampsia		During pregnancy
Secondary	Development of eclampsia		During pregnancy
Secondary	Occurrence of HELP syndrome		During pregnancy
Secondary	Occurrence of preterm labor, preterm premature rupture of the membranes		During pregnancy
Secondary	Gestational age at delivery		End of pregnancy