Expired Study
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Jackson, Mississippi 39216


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 summary:

Not desired


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 is Available At:

Original ID:

IRB File # 2003-0119



Secondary ID:

Study Acronym:

Brief Title:

Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

Official Title:

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

Overall Status:


Study Phase:




Minimum Age:

18 Years

Maximum Age:

44 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Mississippi Medical Center

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Case Control, Time Perspecti

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:May 2004
Completion Date:August 2011
Completion Type:Actual
Primary Completion Date:August 2011
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 3, 2012
First Received Date:December 20, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The observed incidence of preterm labor, premature rupture of membranes, perinatal loss
Time Frame:First, second and third trimester
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Development of preeclampsia during pregnancy
Time Frame:Preeclampsia at any time during gestation
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:4
Description:High Risk Pregnancy, Active Food Supplement
Study Arm Type:Other
Arm Name:3
Description:High Risk Pregnancy, Placebo
Study Arm Type:Other
Arm Name:2
Description:Low Risk Pregnancy, Active Food Supplement
Study Arm Type:Other
Arm Name:1
Description:Low Risk Pregnancy, Placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Mississippi Medical Center

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Blood to be analyzed for various markers, then discarded, none to be retained.
Study Population: Patients cared for in the University of Mississippi Medical Center
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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