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Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

Primary Purpose

Preeclampsia

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Vitamin C 1000mg and E 400IU
Sponsored by
Showa University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia focused on measuring antioxidant supplementation, preeclampsia, prevention

Eligibility Criteria

17 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo National Hospital

Outcomes

Primary Outcome Measures

preeclampsia cases

Secondary Outcome Measures

adverse pregnancy outcome

Full Information

First Posted
October 16, 2006
Last Updated
February 16, 2010
Sponsor
Showa University
Collaborators
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT00388856
Brief Title
Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Official Title
Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Showa University
Collaborators
Indonesia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
antioxidant supplementation, preeclampsia, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vitamin C 1000mg and E 400IU
Primary Outcome Measure Information:
Title
preeclampsia cases
Secondary Outcome Measure Information:
Title
adverse pregnancy outcome

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akihiko Sekizawa, MD, PhD
Organizational Affiliation
Showa University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

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Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

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