Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00583635
First received: December 20, 2007
Last updated: October 3, 2012
Last verified: October 2012
  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.


Condition
Preeclampsia
Pregnancy Loss

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Development of preeclampsia during pregnancy [ Time Frame: Preeclampsia at any time during gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The observed incidence of preterm labor, premature rupture of membranes, perinatal loss [ Time Frame: First, second and third trimester ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood to be analyzed for various markers, then discarded, none to be retained.


Enrollment: 684
Study Start Date: May 2004
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/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

Detailed Description:

Not desired

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients cared for in the University of Mississippi Medical Center

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583635

Locations
United States, Mississippi
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
  More Information

No publications provided

Responsible Party: James Martin, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00583635     History of Changes
Other Study ID Numbers: IRB File # 2003-0119
Study First Received: December 20, 2007
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Preeclampsia
Prevention
Food Supplement

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014