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Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

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.
 
ClinicalTrials.gov Identifier: NCT00583635
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center

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
Preeclampsia Pregnancy Loss

Detailed Description:
Not desired

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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 2004
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Group/Cohort
1
Low Risk Pregnancy, Placebo
2
Low Risk Pregnancy, Active Food Supplement
3
High Risk Pregnancy, Placebo
4
High Risk Pregnancy, Active Food Supplement



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

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: James N Martin, Jr., MD University of Mississippi Medical Center
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Responsible Party: James Martin, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00583635    
Other Study ID Numbers: IRB File # 2003-0119
First Posted: December 31, 2007    Key Record Dates
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:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications