Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

July 1, 2009

Start Date ^ICMJE

May 2004

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Development of preeclampsia during pregnancy [ Time Frame: Preeclampsia at any time during gestation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00583635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The observed incidence of preterm labor, premature rupture of membranes, perinatal loss [ Time Frame: First, second and third trimester ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

Official Title ^ICMJE

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. Study sponsored by NSA, LLC.

Detailed Description

Not desired

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Preeclampsia
Pregnancy Loss

Intervention ^ICMJE

Study Arms / Comparison Groups

Low Risk Pregnancy, Placebo
Low Risk Pregnancy, Active Food Supplement
High Risk Pregnancy, Placebo
High Risk Pregnancy, Active Food Supplement

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: James N Martin, Jr, MD

601-984-6719

jnmartin@ob-gyn.umsmed.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00583635

Responsible Party

James N. Martin, Jr., MD, Professor OBGYN, University of Mississippi Medical Center

Study ID Numbers ^ICMJE

IRB File # 2003-0119

Study Sponsor ^ICMJE

University of Mississippi Medical Center

Collaborators ^ICMJE

NSA, LLC

Investigators ^ICMJE

Principal Investigator:

James N Martin, Jr., MD

University of Mississippi Medical Center

Information Provided By

University of Mississippi Medical Center

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP