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

This study has been completed.
Sponsor:
Collaborators:
Baylor Health Care System
Women's Clinic Shoals
Gainesville Obstetrics & Gynecology
Womens Health Associates
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT01062958
First received: February 3, 2010
Last updated: April 12, 2013
Last verified: April 2013

February 3, 2010
April 12, 2013
December 2009
February 2010   (final data collection date for primary outcome measure)
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. [ Time Frame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062958 on ClinicalTrials.gov Archive Site
  • To determine the effect of Neevo®/Neevo®DHA versus standard prenatal vitamins on red blood cell (RBC) levels in pregnant women. [ Time Frame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery. ] [ Designated as safety issue: No ]
  • To determine if Neevo®/Neevo®DHA administration during pregnancy results in fewer anemias than with standard prenatal vitamins. [ Time Frame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
A Retrospective Analysis of Neevo® and Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy (N-001)

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Pregnant Women Who Received Neevo®/Neevo® DHA or Another Standard Prenatal Vitamin

  • Anemia in Pregnancy
  • Preeclampsia
  • Other: Neevo® (a medical food)
  • Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)
  • Arm #1 (Test group)
    50 subjects administered Neevo® or Neevo®DHA daily
    Intervention: Other: Neevo® (a medical food)
  • Arm #2 (Control group)
    50 subjects administered a prenatal vitamin daily
    Intervention: Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)
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.2011.02.010. Epub 2011 Mar 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Female
21 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01062958
N-001
No
Pamlab, Inc.
Pamlab, Inc.
  • Baylor Health Care System
  • Women's Clinic Shoals
  • Gainesville Obstetrics & Gynecology
  • Womens Health Associates
Principal Investigator: Susan Bentley, CRNP Women's Clinic Shoals
Pamlab, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP