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Sponsors and Collaborators: |
Showa University Indonesia University |
Information provided by: | Showa University |
ClinicalTrials.gov Identifier: | NCT00388856 |
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
Condition | Intervention | Phase |
Preeclampsia |
Drug: Vitamin C 1000mg and E 400IU |
Phase II |
MedlinePlus related topics: | Antioxidants |
ChemIDplus related topics: | Ascorbic acid |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status |
Estimated Enrollment: | 400 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2007 |
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
Ages Eligible for Study: | 17 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Akihiko Sekizawa, MD, PhD | +81 03 3784 8551 | sekizawa@med.showa-u.ac.jp |
Contact: Yuditiya Purwosunu, MD | +81 03 3784 8223 | yudi@med.showa-u.ac.jp |
Indonesia | |||||
Cipto Mangunkusumo National Hospital | Recruiting | ||||
Jakarta, Indonesia, 10430 | |||||
Contact: Edwina Frisdiantiny, MD +62 81380736510 petitedwina@gmail.com | |||||
Principal Investigator: Noroyono Wibowo, MD | |||||
Principal Investigator: Gulardi H Wiknjosastro, MD, PhD | |||||
Sub-Investigator: Edwina Frisdiantiny, MD |
Showa University |
Indonesia University |
Principal Investigator: | Akihiko Sekizawa, MD, PhD | Showa University School of Medicine |
Study ID Numbers: | 17791137 |
First Received: | October 16, 2006 |
Last Updated: | March 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00388856 |
Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
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