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CompletedNCT00583635Updated Oct 5, 2012

Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

An observational study in Preeclampsia and Pregnancy Loss, sponsored by University of Mississippi Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2012-10-05.

Sponsored by University of Mississippi Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
684
Ages
18 Years to 44 Years
Sex
Female
01

Study summary

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.

Read the detailed description

Not desired

02

Conditions studied

  • Preeclampsia
  • Pregnancy Loss

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Keywords

  • Preeclampsia
  • Prevention
  • Food Supplement
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 684 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients cared for in the University of Mississippi Medical Center

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
684 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 1

    Low Risk Pregnancy, Placebo

  • 2

    Low Risk Pregnancy, Active Food Supplement

  • 3

    High Risk Pregnancy, Placebo

  • 4

    High Risk Pregnancy, Active Food Supplement

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What researchers measure

Primary outcomes

  1. Development of preeclampsia during pregnancy

    Time frame: Preeclampsia at any time during gestation

Secondary outcomes

  1. The observed incidence of preterm labor, premature rupture of membranes, perinatal loss

    Time frame: First, second and third trimester

07

Study locations

1 site
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00583635
Lead sponsor
University of Mississippi Medical Center
Responsible party
James Martin (Professor, University of Mississippi Medical Center) — Principal investigator
First posted
Dec 31, 2007
Start date
May 2004
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Oct 5, 2012

Study contacts

James N Martin, Jr., MD
principal investigator · University of Mississippi Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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