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NCT Number: NCT01062958

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

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.

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Key information

Conditions

Anemia in Pregnancy Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases

Age range

21 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Women's Clinic Shoals, Sheffield, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neevo® (a medical food)

Other

Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)

Other

Primary outcomes

  1. 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.

    Time frame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.

Secondary outcomes

  1. To determine the effect of Neevo®/Neevo®DHA versus standard prenatal vitamins on red blood cell (RBC) levels in pregnant women.

    Time frame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.

  2. To determine if Neevo®/Neevo®DHA administration during pregnancy results in fewer anemias than with standard prenatal vitamins.

    Time frame: At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.

Sponsors and collaborators

Lead sponsor

Pamlab, Inc.

Industry

Collaborators

  • Baylor Health Care System
  • Gainesville Obstetrics & Gynecology
  • Women's Clinic Shoals
  • Womens Health Associates

Registry information

Official study title

A Retrospective Analysis of Neevo® and Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy (N-001)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2010
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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