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Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

This study has been completed.
Sponsor:
Collaborator:
Indonesia University
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
NCT00388856
First received: October 16, 2006
Last updated: February 16, 2010
Last verified: March 2007
History of Changes

October 16, 2006
February 16, 2010
October 2006
November 2009   (final data collection date for primary outcome measure)
preeclampsia cases
Same as current
Complete list of historical versions of study NCT00388856 on ClinicalTrials.gov Archive Site
adverse pregnancy outcome
Same as current
Not Provided
Not Provided
 
Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Preeclampsia
Drug: Vitamin C 1000mg and E 400IU
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
February 2010
November 2009   (final data collection date for primary outcome measure)

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
Female
17 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT00388856
17791137
Yes
Yuditiya Purwosunu, Univ. Indonesia
Showa University
Indonesia University
Principal Investigator: Akihiko Sekizawa, MD, PhD Showa University School of Medicine
Showa University
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP