PreeclampsiaNCT00583635
Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia
An observational study of Preeclampsia and Pregnancy Loss, run by University of Mississippi Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Preeclampsia, Pregnancy Loss
- How many people
- 684 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients cared for in the University of Mississippi Medical Center
Who may be able to join
- Pregnant Patients seen in first trimester with low or high risk pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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
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.
Read the detailed description
Not desired
- Conditions
- Preeclampsia, Pregnancy Loss
- Keywords
- Preeclampsia, Prevention, Food Supplement
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Low Risk Pregnancy, Placebo | |
| 2 | Low Risk Pregnancy, Active Food Supplement | |
| 3 | High Risk Pregnancy, Placebo | |
| 4 | High Risk Pregnancy, Active Food Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of preeclampsia during pregnancy
Measured: Preeclampsia at any time during gestation
Secondary outcomes (1)
The observed incidence of preterm labor, premature rupture of membranes, perinatal loss
Measured: First, second and third trimester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startMay 2004
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Martin, University of Mississippi Medical Center
- Investigators
- James N Martin, Jr., MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583635
- Sponsor's protocol ID
- IRB File # 2003-0119
- Status last verified
- Oct 2012
- First submitted
- 20 Dec 2007
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00583635
- Acronym / sponsor ID
- IRB File # 2003-0119
- Conditions
- Preeclampsia, Pregnancy Loss
- Keywords
- Preeclampsia, Prevention, Food Supplement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Low Risk Pregnancy, Placebo |
| 2 | – | –Low Risk Pregnancy, Active Food Supplement |
| 3 | – | –High Risk Pregnancy, Placebo |
| 4 | – | –High Risk Pregnancy, Active Food Supplement |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients cared for in the University of Mississippi Medical Center
Key inclusion criteria (1 listed)
- Pregnant Patients seen in first trimester with low or high risk pregnancy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of preeclampsia during pregnancy
Time frame: Preeclampsia at any time during gestation
1 secondary outcome
The observed incidence of preterm labor, premature rupture of membranes, perinatal loss
Time frame: First, second and third trimester
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James N Martin, Jr., MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Pregnancy Loss, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of preeclampsia during pregnancy (time frame: Preeclampsia at any time during gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.