Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

Preeclampsia Clinical Trial

Official title:

Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388856
• Other study ID #: 17791137
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2006
• Last updated: February 16, 2010
• Start date: October 2006
• Est. completion date: February 2010

Study information

• Verified date: March 2007
• Source: Showa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Vitamin C 1000mg and E 400IU

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Showa University	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preeclampsia cases
Secondary	adverse pregnancy outcome