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

Pre-eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01193192
• Other study ID #: N-002
• Status: Terminated
• Phase: N/A
• First received: August 30, 2010
• Last updated: November 22, 2011
• Start date: July 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2011
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia
• Anemia in Pregnancy
• Pre-eclampsia

Intervention

Other:
• Neevo®
A prenatal "medical food" - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid
• Prenatal vitamins
for inclusion in the Control Group, prenatal vitamins must have contained =1mg folic acid, 27 - 35mg iron, and =12mcg vitamin B12.

Locations

Country	Name	City	State
United States	Five Oaks Medical Group	Chickasha	Oklahoma
United States	Norman Regional Health System	Norman	Oklahoma
United States	Norman Regional Health System	Norman	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
Pamlab, L.L.C.	Baylor Health Care System, Five Oaks Medical Group, Norman Regional Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Hemoglobin (Hgb) Levels	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.	No
Secondary	Mean Change in Hemoglobin (Hgb) Levels	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.	No
Secondary	Incidence of Anemia	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.	No
Secondary	Incidence of Pre-eclampsia	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.	No
Secondary	Mean Infant Birth Rate	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.	No