Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

October 3, 2012 updated by: James Martin, University of Mississippi Medical Center

Minimizing Early Pregnancy Oxidative Stress to Maximize Healthy Pregnancy Outcome: Reducing Preeclampsia and Reproductive Loss With Antioxidant-Rich Tablet Supplementation Initiated in the First Trimester

Use of Juice Plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. This is a prospective randomized and blinded placebo controlled study sponsored by NSA, LLC of Memphis, TN.

Study Overview

Status

Completed

Conditions

Detailed Description

Not desired

Study Type

Observational

Enrollment (Actual)

684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients cared for in the University of Mississippi Medical Center

Description

Inclusion Criteria:

  • Pregnant Patients seen in first trimester with low or high risk pregnancy

Exclusion Criteria:

  • Pregnant patients first seen after the first trimester
  • Unlikely to continue care in our system
  • Unwilling to comply with rigor of taking food supplements throughout gestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Low Risk Pregnancy, Placebo
2
Low Risk Pregnancy, Active Food Supplement
3
High Risk Pregnancy, Placebo
4
High Risk Pregnancy, Active Food Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of preeclampsia during pregnancy
Time Frame: Preeclampsia at any time during gestation
Preeclampsia at any time during gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
The observed incidence of preterm labor, premature rupture of membranes, perinatal loss
Time Frame: First, second and third trimester
First, second and third trimester

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: James N Martin, Jr., MD, University of Mississippi Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

October 5, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB File # 2003-0119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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