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

Sponsor

Pamlab, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01062958

Collaborator

Baylor Health Care System (Other), Women's Clinic Shoals (Other), Gainesville Obstetrics & Gynecology (Other), Womens Health Associates (Other)

100

Enrollment

Locations

Duration (Months)

33.3

Patients Per Site

16.4

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 Neevo®DHA (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 Neevo®DHA daily compared to subjects administered a prenatal vitamin daily.

Condition or Disease	Intervention/Treatment	Phase
Anemia in Pregnancy Preeclampsia	Other: Neevo® (a medical food) Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

A Retrospective Analysis of Neevo® and Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy (N-001)

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Arm #1 (Test group) 50 subjects administered Neevo® or Neevo®DHA daily	Other: Neevo® (a medical food)
Arm #2 (Control group) 50 subjects administered a prenatal vitamin daily	Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)

Arm

Intervention/Treatment

Arm #1 (Test group)

50 subjects administered Neevo® or Neevo®DHA daily

Other: Neevo® (a medical food)

Arm #2 (Control group)

50 subjects administered a prenatal vitamin daily

Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)

Outcome Measures

Primary Outcome Measures

To determine the effect of Neevo®/Neevo®DHA (with higher folate and B12) versus standard prenatal vitamins on hemoglobin levels in pregnant women throughout the course of pregnancy. [At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.]

Secondary Outcome Measures

To determine the effect of Neevo®/Neevo®DHA versus standard prenatal vitamins on red blood cell (RBC) levels in pregnant women. [At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.]
To determine if Neevo®/Neevo®DHA administration during pregnancy results in fewer anemias than with standard prenatal vitamins. [At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.]

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®/Neevo®DHA 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 on or after January 1, 2008 and delivery must have occurred on or before December 31,

Subjects must have been compliant in taking Neevo DHA 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 prior to randomization; 100mg vitamin C, B12 injection >10mg of B6; >32mg Iron; >1.2mg of folate; an L- methylfolate product that is not a prenatal vitamin such as Life Extension methylfolate, Prothera methylfolate, Thorne 5-MTHF, Metanx®, Neevo®, Neevo®DHA, Deplin®, Cerefolin®, or CerefolinNAC®.
History of any anemia other than iron deficiency anemia or leukemia.
Blood transfusion in the 4 months prior to diagnosis of pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Clinic Shoals	Sheffield	Alabama	United States	35660
2	Women's Health Associates	Flowood	Mississippi	United States	39232
3	Gainesville Obstetrics & Gynecology	Gainesville	Texas	United States	76240