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Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388856
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : February 17, 2010
Indonesia University
Information provided by:
Showa University

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

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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

Primary Outcome Measures :
  1. preeclampsia cases

Secondary Outcome Measures :
  1. adverse pregnancy outcome

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00388856

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Cipto Mangunkusumo National Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Showa University
Indonesia University
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Principal Investigator: Akihiko Sekizawa, MD, PhD Showa University School of Medicine
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Responsible Party: Yuditiya Purwosunu, Univ. Indonesia Identifier: NCT00388856    
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
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents