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Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

This study is currently recruiting participants.
Verified by University of Mississippi Medical Center, December 2007

Sponsored by: University of Mississippi Medical Center
Information provided by: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00583635
  Purpose

Use of Juice+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. Study sponsored by National Safety Associates, LLC.


Condition
Preeclampsia
Pregnancy Loss

MedlinePlus related topics:   Antioxidants   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, 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

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

Biospecimen Description:

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


Estimated Enrollment:   600
Study Start Date:   May 2004
Estimated Study Completion Date:   April 2009
Estimated Primary Completion Date:   June 2010 (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

Contacts
Contact: James N Martin, Jr, MD     601-984-6719     jnmartin@ob-gyn.umsmed.edu    

Locations
United States, Mississippi
University of Mississippi Medical Center     Recruiting
      Jackson, Mississippi, United States, 39216
      Contact: James N Martin, Jr., MD     601-984-6719     jnmartin@ob-gyn.umsmed.edu    
      Contact: Pamela Tazik     601-815-5007     ptazik@dor.umsmed.edu    
      Principal Investigator: James N Martin, Jr, MD            

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:   Professor OBGYN, University of Mississippi Medical Center ( James N. Martin, Jr., MD )
Study ID Numbers:   IRB File # 2003-0119
First Received:   December 20, 2007
Last Updated:   December 28, 2007
ClinicalTrials.gov Identifier:   NCT00583635
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pregnancy toxemia /hypertension
Stress
Pre-Eclampsia
Healthy
Preeclampsia
Hypertension

ClinicalTrials.gov processed this record on September 05, 2008




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