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

Stopped early

Conditions studied: Anemia in Pregnancy, Pre-eclampsia

In brief

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.

Key facts

Study ID

NCT01193192

Run by

Pamlab, L.L.C.

People needed

30

Starts

2010-07-01

Expected to finish

2010-11-01

Last updated by the study team

2011-11-23

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®/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

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 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

Where it is running

• Five Oaks Medical Group — Chickasha, Oklahoma, United States
• Norman Regional Health System — Norman, Oklahoma, United States
• Norman Regional Health System — Norman, Oklahoma, United States

Full record on ClinicalTrials.gov

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