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Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Preeclampsia | Drug: Vitamin C 1000mg and E 400IU | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
- preeclampsia cases
- adverse pregnancy outcome
| Enrollment: | 400 |
| Study Start Date: | October 2006 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
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
Eligibility| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00388856
| Indonesia | |
| Cipto Mangunkusumo National Hospital | |
| Jakarta, Indonesia, 10430 | |
| Principal Investigator: | Akihiko Sekizawa, MD, PhD | Showa University School of Medicine |
More Information
| Responsible Party: | Yuditiya Purwosunu, Univ. Indonesia |
| ClinicalTrials.gov Identifier: | NCT00388856 History of Changes |
| Other Study ID Numbers: |
17791137 |
| Study First Received: | October 16, 2006 |
| Last Updated: | February 16, 2010 |
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 |
ClinicalTrials.gov processed this record on August 21, 2017