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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Showa University:

Primary Outcome Measures:
  • preeclampsia cases

Secondary Outcome Measures:
  • adverse pregnancy outcome

Enrollment: 400
Study Start Date: October 2006
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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

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

No publications provided

Responsible Party: Yuditiya Purwosunu, Univ. Indonesia
ClinicalTrials.gov Identifier: NCT00388856     History of Changes
Other Study ID Numbers: 17791137
Study First Received: October 16, 2006
Last Updated: February 16, 2010
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Showa University:
antioxidant supplementation
preeclampsia
prevention

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antioxidants
Ascorbic Acid
Vitamins
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013