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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062958
• Other study ID #: N-001
• Status: Completed
• Phase: N/A
• First received: February 3, 2010
• Last updated: April 12, 2013
• Start date: December 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2013
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2010
• Est. primary completion date: February 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®/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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia
• Anemia in Pregnancy
• Preeclampsia

Intervention

Other:
• Neevo® (a medical food)

• Prenatal vitamins (=1mg folic acid, 27 - 35mg iron, and =12mcg vitamin B12)

Locations

Country	Name	City	State
United States	Women's Health Associates	Flowood	Mississippi
United States	Gainesville Obstetrics & Gynecology	Gainesville	Texas
United States	Women's Clinic Shoals	Sheffield	Alabama

Sponsors (5)

Lead Sponsor	Collaborator
Pamlab, Inc.	Baylor Health Care System, Gainesville Obstetrics & Gynecology, Women's Clinic Shoals, Womens Health Associates

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bentley S, Hermes A, Phillips D, Daoud YA, Hanna S. Comparative effectiveness of a prenatal medical food to prenatal vitamins on hemoglobin levels and adverse outcomes: a retrospective analysis. Clin Ther. 2011 Feb;33(2):204-10. doi: 10.1016/j.clinthera.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No