Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Jackson, Mississippi 39216


Purpose:

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


Criteria:

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


NCT ID:

NCT00583635


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:

Completed


Study Phase:

N/A


Genders:

Female


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:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

684


Enrollment Type:

Actual


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.