Clinical trial NCT01062958: A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
Official title: A Retrospective Analysis of Neevo® and Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy (N-001)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia in Pregnancy
Preeclampsia
Keywords: Neevo
Neevo DHA
L-methylfolate
anemia during pregnancy
folic acid
vitamin B12
prenatal vitamins
hemoglobin
iron deficiency
Pregnancy
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Baylor Health Care System
name: Women's Clinic Shoals
name: Gainesville Obstetrics & Gynecology
name: Womens Health Associates
First posted: 2010-02-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant Women Who Received Neevo®/Neevo® DHA or Another Standard Prenatal Vitamin

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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.
Secondary outcomes:
measure: To determine the effect of Neevo®/Neevo®DHA versus standard prenatal vitamins on red blood cell (RBC) levels in pregnant women.
timeFrame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.
measure: To determine if Neevo®/Neevo®DHA administration during pregnancy results in fewer anemias than with standard prenatal vitamins.
timeFrame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Women's Clinic Shoals
state: Alabama
city: Flowood
country: United States
facility: Women's Health Associates
state: Mississippi
city: Gainesville
country: United States
facility: Gainesville Obstetrics & Gynecology
state: Texas
Study officials:
affiliation: Women's Clinic Shoals
name: Susan Bentley, CRNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.