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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

Tracking Information
First Submitted Date December 20, 2007
First Posted Date December 31, 2007
Last Update Posted Date October 5, 2012
Study Start Date May 2004
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 28, 2007)
Development of preeclampsia during pregnancy [ Time Frame: Preeclampsia at any time during gestation ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 28, 2007)
The observed incidence of preterm labor, premature rupture of membranes, perinatal loss [ Time Frame: First, second and third trimester ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Detailed Description Not desired
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood to be analyzed for various markers, then discarded, none to be retained.
Sampling Method Non-Probability Sample
Study Population Patients cared for in the University of Mississippi Medical Center
Condition
  • Preeclampsia
  • Pregnancy Loss
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 3, 2012)
684
Original Estimated Enrollment
 (submitted: December 28, 2007)
600
Actual Study Completion Date August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00583635
Other Study ID Numbers IRB File # 2003-0119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party James Martin, University of Mississippi Medical Center
Study Sponsor University of Mississippi Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: James N Martin, Jr., MD University of Mississippi Medical Center
PRS Account University of Mississippi Medical Center
Verification Date October 2012