L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia

NCT ID: NCT00469846

Last Updated: 2007-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 585 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2006-11-30

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.

Conditions

Pre-Eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

L-arginine supplementation in a medical food

Intervention Type: PROCEDURE

Vitamin C and E supplementation in a medical food

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 32 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Felipe Vadillo-Ortega, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Locations

Univesity of Pennsylvania

Philadelphia, Pennsylvania, United States

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Mexico City, D.F., Mexico

Countries

United States; Mexico

References

Vadillo-Ortega F, Perichart-Perera O, Espino S, Avila-Vergara MA, Ibarra I, Ahued R, Godines M, Parry S, Macones G, Strauss JF. Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial. BMJ. 2011 May 19;342:d2901. doi: 10.1136/bmj.d2901.

Reference Type: DERIVED

PMID: 21596735 (View on PubMed)

Other Identifiers

212250-02071

Identifier Type: -

Identifier Source: org_study_id