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:

Genetics Home Reference related topics: preeclampsia

MedlinePlus related topics: Antioxidants Vitamin C

Drug Information available for: Ascorbic acid Sodium ascorbate Magnesium ascorbate

Genetic and Rare Diseases Information Center resources: Eclampsia

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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Vitamins Ascorbic Acid Antioxidants	Micronutrients Growth Substances Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Protective Agents

ClinicalTrials.gov processed this record on September 23, 2016

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