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Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583635
First Posted: December 31, 2007
Last Update Posted: October 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center
  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 James Martin, University of Mississippi Medical Center:

Primary Outcome Measures:
  • Development of preeclampsia during pregnancy [ Time Frame: Preeclampsia at any time during gestation ]

Secondary Outcome Measures:
  • The observed incidence of preterm labor, premature rupture of membranes, perinatal loss [ Time Frame: First, second and third trimester ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 20, 2007
First Posted: December 31, 2007
Last Update Posted: October 5, 2012
Last Verified: October 2012

Keywords provided by James Martin, 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
Protective Agents
Physiological Effects of Drugs