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

Sponsor

Pamlab, L.L.C. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01193192

Collaborator

Baylor Health Care System (Other), Norman Regional Health System (Other), Five Oaks Medical Group (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia in Pregnancy Pre-eclampsia	Other: Neevo® Other: Prenatal vitamins

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Mean Hemoglobin (Hgb) Levels [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.

Secondary Outcome Measures

Mean Change in Hemoglobin (Hgb) Levels [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.
Incidence of Anemia [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.
Incidence of Pre-eclampsia [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.
Mean Infant Birth Rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Five Oaks Medical Group	Chickasha	Oklahoma	United States	73018
2	Norman Regional Health System	Norman	Oklahoma	United States	73071
3	Norman Regional Health System	Norman	Oklahoma	United States	73072