RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

Summary

The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.

Conditions

• Preeclampsia
• Eclampsia
• HELLP Syndrome
• Pregnancy

Interventions

DRUG

Vitamin C and E

Sponsors & Collaborators

• Global Network for Women's and Children's Health Research

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• RTI International

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Universidade Federal de Pernambuco

  collaborator OTHER

• Feculdade de Medicina da Universidade de Sao Paulo - Brasil

  collaborator OTHER

• Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

  collaborator OTHER

• University of Campinas, Brazil

  collaborator OTHER

• Hospital de Clinicas de Porto Alegre

  collaborator OTHER

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Principal Investigators

• Joseph A. Spinnato, M.D. · University of Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-07-31

Completion

2006-12-31

Countries

• Brazil

Study Locations