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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
Sponsor:
Collaborator:
Indonesia University
Information provided by:
Showa University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Vitamin C 1000mg and E 400IU Phase 2

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


Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. preeclampsia cases

Secondary Outcome Measures :
  1. adverse pregnancy outcome

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
Indonesia
Cipto Mangunkusumo National Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Showa University
Indonesia University
Investigators
Principal Investigator: Akihiko Sekizawa, MD, PhD Showa University School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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