Clinical trial NCT01193192: A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
Official title: A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anemia in Pregnancy
Pre-eclampsia
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: Norman Regional Health System
name: Five Oaks Medical Group
First posted: 2010-09-01
Enrollment: 30
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®/NeevoDHA® or Another Standard Prenatal Vitamin

Brief summary: This study is a multi-site, retrospective chart review to determine the effect of Neevo® or NeevoDHA® (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 NeevoDHA® daily compared to subjects administered a prenatal vitamin daily.


Eligibility criteria: Inclusion Criteria:

* Pregnant females, age 21-39, who received either Neevo®/NeevoDHA® 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 delivery must have occurred on or after January 1, 2008 and on or before March 31, 2010
* Subjects must have been compliant in taking Neevo®/NeevoDHA® 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 of diagnosis of pregnancy: B12 injection; \> 35mg Iron; \> 1.2 mg of folate; or a L-methylfolate product that is not a prenatal vitamin such as Life Extension methylfolate, Prothera methylfolate, Thorne 5-MTHF, Metanx®, Deplin®, Cerefolin®, or CerefolinNAC®
* History of leukemia or any anemia other than iron deficiency anemia or;
* Taking any iron supplement (in addition to the prenatal vitamin) prior to Week 22

Primary outcomes:
measure: Mean Hemoglobin (Hgb) Levels
timeFrame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
Secondary outcomes:
measure: Mean Change in Hemoglobin (Hgb) Levels
timeFrame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
measure: Incidence of Anemia
timeFrame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
measure: Incidence of Pre-eclampsia
timeFrame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
measure: Mean Infant Birth Rate
timeFrame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
Other outcomes:
Locations:
city: Chickasha
country: United States
facility: Five Oaks Medical Group
state: Oklahoma
city: Norman
country: United States
facility: Norman Regional Health System
state: Oklahoma
city: Norman
country: United States
facility: Norman Regional Health System
state: Oklahoma
Study officials:
affiliation: Norman Regional Health System
name: Nicole Jarvis, M.D.
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.