Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
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ClinicalTrials.gov Identifier: NCT00388856 |
Recruitment Status
:
Completed
First Posted
: October 17, 2006
Last Update Posted
: February 17, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preeclampsia | Drug: Vitamin C 1000mg and E 400IU | Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | February 2010 |

- preeclampsia cases
- adverse pregnancy outcome

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Ages Eligible for Study: | 17 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388856
Indonesia | |
Cipto Mangunkusumo National Hospital | |
Jakarta, Indonesia, 10430 |
Principal Investigator: | Akihiko Sekizawa, MD, PhD | Showa University School of Medicine |
Responsible Party: | Yuditiya Purwosunu, Univ. Indonesia |
ClinicalTrials.gov Identifier: | NCT00388856 History of Changes |
Other Study ID Numbers: |
17791137 |
First Posted: | October 17, 2006 Key Record Dates |
Last Update Posted: | February 17, 2010 |
Last Verified: | March 2007 |
Keywords provided by Showa University:
antioxidant supplementation preeclampsia prevention |
Additional relevant MeSH terms:
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Vitamins Ascorbic Acid Antioxidants |
Micronutrients Growth Substances Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Protective Agents |