L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia (L-Arg)

May 7, 2007 updated by: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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

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.

Study Overview

Status

Terminated

Conditions

Pre-Eclampsia

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

585

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- D.f.
  - Mexico City, D.f., Mexico, 11000
    - Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-6142
    - Univesity of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 32 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of preeclampsia Time Frame: During pregnancy	During pregnancy

Secondary Outcome Measures

Outcome Measure	Time Frame
Development of eclampsia Time Frame: During pregnancy	During pregnancy
Occurrence of HELP syndrome Time Frame: During pregnancy	During pregnancy
Occurrence of preterm labor, preterm premature rupture of the membranes Time Frame: During pregnancy	During pregnancy
Gestational age at delivery Time Frame: End of pregnancy	End of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Collaborators

University of Pennsylvania

Bill and Melinda Gates Foundation

Investigators

Principal Investigator: Felipe Vadillo-Ortega, M.D.,Ph.D., Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 4, 2007

First Submitted That Met QC Criteria