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

Completed

Conditions studied: Anemia in Pregnancy, Preeclampsia

In brief

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.

Key facts

Study ID

NCT01062958

Run by

Pamlab, Inc.

People needed

100

Starts

2009-12-01

Expected to finish

2010-02-01

Last updated by the study team

2013-04-16

Who can join

Age: 21 and older, up to 39. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Women's Clinic Shoals — Sheffield, Alabama, United States
• Women's Health Associates — Flowood, Mississippi, United States
• Gainesville Obstetrics & Gynecology — Gainesville, Texas, United States

Full record on ClinicalTrials.gov

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