MedDataX Logo

Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

NCT ID: NCT00583635

Last Updated: 2012-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

684 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Not desired

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preeclampsia Pregnancy Loss

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Preeclampsia Prevention Food Supplement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Low Risk Pregnancy, Placebo

No interventions assigned to this group

2

Low Risk Pregnancy, Active Food Supplement

No interventions assigned to this group

3

High Risk Pregnancy, Placebo

No interventions assigned to this group

4

High Risk Pregnancy, Active Food Supplement

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James Martin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James N Martin, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB File # 2003-0119

Identifier Type: -

Identifier Source: org_study_id