A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy

November 22, 2011 updated by: Pamlab, L.L.C.
This study is a multi-site, retrospective chart review to determine the effect of Neevo® or NeevoDHA® (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical food indicated for the dietary management of women under a doctor's care who face high risk pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize folic acid. Data will be collected from existing patient charts of subjects administered Neevo® or NeevoDHA® daily compared to subjects administered a prenatal vitamin daily.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Chickasha, Oklahoma, United States, 73018
        • Five Oaks Medical Group
      • Norman, Oklahoma, United States, 73071
        • Norman Regional Health System
      • Norman, Oklahoma, United States, 73072
        • Norman Regional Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant Women Who Received Neevo®/NeevoDHA® or Another Standard Prenatal Vitamin

Description

Inclusion Criteria:

  • Pregnant females, age 21-39, who received either Neevo®/NeevoDHA® or another standard prenatal vitamin (Prenatal vitamins must contain ≤1 mg folic acid, 27-35mg iron, and ≤12mcg vitamin B12).
  • Clinical diagnosis of pregnancy must have been made at ≤12 weeks of Pregnancy, and delivery must have occurred on or after January 1, 2008 and on or before March 31, 2010
  • Subjects must have been compliant in taking Neevo®/NeevoDHA® or other prenatal vitamin

Exclusion Criteria:

  • Subjects should not have taken Prenate®, Prenate®DHA, or Prenate® Elite, which are L-methylfolate-containing prenatal vitamins.
  • The following supplements within 2 months of diagnosis of pregnancy: B12 injection; > 35mg Iron; > 1.2 mg of folate; or a L-methylfolate product that is not a prenatal vitamin such as Life Extension methylfolate, Prothera methylfolate, Thorne 5-MTHF, Metanx®, Deplin®, Cerefolin®, or CerefolinNAC®
  • History of leukemia or any anemia other than iron deficiency anemia or;
  • Taking any iron supplement (in addition to the prenatal vitamin) prior to Week 22

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm #1 (Test Group)
100 subject administered Neevo® or NeevoDHA® daily
Other: Neevo®
A prenatal "medical food" - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid
Arm #2 (Control group)
100 subject administered a prenatal vitamin daily
Other: Prenatal vitamins
for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Hemoglobin (Hgb) Levels
Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy.
At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Hemoglobin (Hgb) Levels
Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean change in hemoglobin levels in pregnant women.
At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
Incidence of Anemia
Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer incidences of anemia than with standard prenatal vitamins.
At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
Incidence of Pre-eclampsia
Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer cases of pre-eclampsia than with standard prenatal vitamins.
At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
Mean Infant Birth Rate
Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on infant birth weight.
At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamlab, L.L.C.

Collaborators

Baylor Health Care System
Norman Regional Health System
Five Oaks Medical Group

Investigators

  • Principal Investigator: Nicole Jarvis, M.D., Norman Regional Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pre-eclampsia

Clinical Trials on Neevo®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe