Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

This study is ongoing, but not recruiting participants.

First Received on December 20, 2007. Last Updated on August 2, 2011 History of Changes

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

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:

MedlinePlus related topics: Antioxidants Dietary Supplements

U.S. FDA Resources

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.

Estimated Enrollment:	300
Study Start Date:	May 2004
Estimated Study Completion Date:	December 2011
Estimated 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 N. Martin, Jr., MD, Professor OBGYN, 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:	August 2, 2011
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 February 12, 2012