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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01062958
Other study ID # N-001
Secondary ID
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


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
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