NCT00388856

Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Showa University · Academic / Other
• Sex: Female
• Age: 17 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Vitamin C 1000mg and E 400IU

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-11-01
• Completion: 2010-02-01
• First posted: 2006-10-17
• Last updated: 2010-02-17

Locations

1 site across 1 country: Indonesia