Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583635
• Other study ID #: IRB File # 2003-0119
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: October 3, 2012
• Start date: May 2004
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Not desired

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia
• Pregnancy Loss

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of preeclampsia during pregnancy		Preeclampsia at any time during gestation	No
Secondary	The observed incidence of preterm labor, premature rupture of membranes, perinatal loss		First, second and third trimester	No