Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

NCT ID: NCT00388856

Last Updated: 2010-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-02-28

Brief Summary

The purpose of this study is to investigate antioxidants supplementation in pregnant women with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy outcome in randomized prospective study.

Detailed Description

Preeclampsia still remains a leading cause of feto-maternal mortality and morbidity in developed and developing world. Despite of intensive research, the underlying pathologic mechanisms of this disease remain elusive. It has been agreed that incomplete or absent transformation of spiral arteries by replacing endothelial cells and mural vascular smooth muscle cells has been observed in the placental bed of preeclamptic patients and severe cases of intrauterine growth restriction. Oxidative stress has been proposed as a link between these mechanisms. However, it has been demonstrated by two large studies that antioxidant supplementation does not reduce the risk of preeclampsia. Our initial study has been shown that antioxidant supplementation may be reduce the risk of preeclampsia in pregnant women with low antioxidant status.

Comparison(s): adverse pregnancy outcome between vitamin C and E given and placebo given to pregnant women with low antioxidant status at 10-12 weeks gestation age

Conditions

Preeclampsia

Study Design

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

Interventions

Vitamin C 1000mg and E 400IU

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Agree to consent form, and consent to protocol of research
• Known healthy singleton 6-10 weeks pregnant women

Exclusion Criteria

• Blood pressure > 135/85
• Proteinuria
• History or current use of anti-hypertensive medication or diuretics
• Use of vitamins C > 150 mg and/or E > 75 IU per day
• Pregestational diabetes
• Known placental abnormalities.
• Current pregnancy is a result of in vitro fertilization
• Regular use of platelet active drugs or non-steroidal anti-inflammatory drugs
• Known fetal abnormalities
• Documented uterine bleeding within a week of screening
• Uterine malformations
• History of medical complications
• Illicit drug or alcohol abuse during current pregnancy
• Intent to deliver elsewhere
• Known psychologic problems.
• Participating in another interventional study

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: collaborator

Showa University

OTHER

Sponsor Role: lead

Responsible Party

Univ. Indonesia

Principal Investigators

Akihiko Sekizawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Showa University School of Medicine

Locations

Cipto Mangunkusumo National Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

17791137

Identifier Type: -

Identifier Source: org_study_id