Early Pregnancy Antioxidant Supplementation in the Preven... | NCT00583635

Studies
Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

NCT00583635

Sponsor

University of Mississippi Medical Center

Status

Completed

Last Update Posted

Oct 5, 2012Estimated

Enrollment

684Actual

Phase

Not provided

Conditions

Preeclampsia
Pregnancy Loss

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 28, 2007

First Posted Date

Dec 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2012

Last Update Posted Date

Oct 5, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

James Martin, Professor, University of Mississippi Medical CenterPrincipal Investigator

Lead Sponsor

University of Mississippi Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not desired

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

684Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Low Risk Pregnancy, Placebo
2		Low Risk Pregnancy, Active Food Supplement
3		High Risk Pregnancy, Placebo
4		High Risk Pregnancy, Active Food Supplement

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of preeclampsia during pregnancy		Preeclampsia at any time during gestation

Secondary Outcomes

Measure	Description	Time Frame
The observed incidence of preterm labor, premature rupture of membranes, perinatal loss		First, second and third trimester

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Patients cared for in the University of Mississippi Medical Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James N Martin, Jr., MD	University of Mississippi Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Mississippi Medical Center		Jackson	Mississippi	39216	United States

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided