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Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

This study is currently recruiting participants.
Verified by Showa University, March 2007

Sponsors and Collaborators: Showa University
Indonesia University
Information provided by: Showa University
ClinicalTrials.gov Identifier: NCT00388856
  Purpose

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 Intervention Phase
Preeclampsia
Drug: Vitamin C 1000mg and E 400IU
Phase II

MedlinePlus related topics:   Antioxidants   

ChemIDplus related topics:   Ascorbic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status

Further study details as provided by Showa University:

Primary Outcome Measures:
  • preeclampsia cases

Secondary Outcome Measures:
  • adverse pregnancy outcome

Estimated Enrollment:   400
Study Start Date:   October 2006
Estimated Study Completion Date:   October 2007

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

  Eligibility
Ages Eligible for Study:   17 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388856

Contacts
Contact: Akihiko Sekizawa, MD, PhD     +81 03 3784 8551     sekizawa@med.showa-u.ac.jp    
Contact: Yuditiya Purwosunu, MD     +81 03 3784 8223     yudi@med.showa-u.ac.jp    

Locations
Indonesia
Cipto Mangunkusumo National Hospital     Recruiting
      Jakarta, Indonesia, 10430
      Contact: Edwina Frisdiantiny, MD     +62 81380736510     petitedwina@gmail.com    
      Principal Investigator: Noroyono Wibowo, MD            
      Principal Investigator: Gulardi H Wiknjosastro, MD, PhD            
      Sub-Investigator: Edwina Frisdiantiny, MD            

Sponsors and Collaborators
Showa University
Indonesia University

Investigators
Principal Investigator:     Akihiko Sekizawa, MD, PhD     Showa University School of Medicine    
  More Information


Study ID Numbers:   17791137
First Received:   October 16, 2006
Last Updated:   March 19, 2007
ClinicalTrials.gov Identifier:   NCT00388856
Health Authority:   Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Showa University:
antioxidant supplementation  
preeclampsia  
prevention  

Study placed in the following topic categories:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pregnancy toxemia /hypertension
Pre-Eclampsia
Preeclampsia
Ascorbic Acid
Hypertension

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008




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