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

Completed

• Conditions: Anemia in Pregnancy; Preeclampsia
• Interventions: Other: Neevo® (a medical food); Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)

• Registration Number: NCT01062958
• Lead Sponsor: Pamlab, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-12
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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, 2009.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Women's Health Associates; 🇺🇸 Flowood, Mississippi, United States

Women's Clinic Shoals; 🇺🇸 Sheffield, Alabama, United States

Gainesville Obstetrics & Gynecology; 🇺🇸 Gainesville, Texas, United States