Clincosm LogoSign in Get a demo

Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

Sponsor
University of Mississippi Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00583635
Collaborator
(none)
684
Enrollment
1
Location
87
Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Not desired

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    684 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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
    Study Start Date :
    May 1, 2004
    Actual Primary Completion Date :
    Aug 1, 2011
    Actual Study Completion Date :
    Aug 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Low Risk Pregnancy, Placebo
    2

    Low Risk Pregnancy, Active Food Supplement
    3

    High Risk Pregnancy, Placebo
    4

    High Risk Pregnancy, Active Food Supplement

    Outcome Measures

    Primary Outcome Measures

    1. Development of preeclampsia during pregnancy [Preeclampsia at any time during gestation]

    Secondary Outcome Measures

    1. The observed incidence of preterm labor, premature rupture of membranes, perinatal loss [First, second and third trimester]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Mississippi Medical Center Jackson Mississippi United States 39216

    Sponsors and Collaborators

    • University of Mississippi Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    James Martin, Professor, University of Mississippi Medical Center
    ClinicalTrials.gov Identifier:
    NCT00583635
    Other Study ID Numbers:
    • IRB File # 2003-0119
    First Posted:
    Dec 31, 2007
    Last Update Posted:
    Oct 5, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by James Martin, Professor, University of Mississippi Medical Center
    Preeclampsia
    Prevention
    Food Supplement
    Additional relevant MeSH terms:
    Pre-Eclampsia

    Study Results

    No Results Posted as of Oct 5, 2012