NCT00583635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

7.3 years

First QC Date

December 20, 2007

Last Update Submit

October 3, 2012

Conditions

PreeclampsiaPregnancy Loss

Keywords

PreeclampsiaPreventionFood Supplement

Outcome Measures

Primary Outcomes (1)

  • Development of preeclampsia during pregnancy

    Preeclampsia at any time during gestation

Secondary Outcomes (1)

  • The observed incidence of preterm labor, premature rupture of membranes, perinatal loss

    First, second and third trimester

Study Arms (4)

1

Low Risk Pregnancy, Placebo

2

Low Risk Pregnancy, Active Food Supplement

3

High Risk Pregnancy, Placebo

4

High Risk Pregnancy, Active Food Supplement

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients cared for in the University of Mississippi Medical Center

You may qualify if:

  • Pregnant Patients seen in first trimester with low or high risk pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • James N Martin, Jr., MD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

May 1, 2004

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

US(1)