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

This study has been completed.
Sponsor:
Collaborators:
Baylor Health Care System
Women's Clinic Shoals
Gainesville Obstetrics & Gynecology
Womens Health Associates
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT01062958
First received: February 3, 2010
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Anemia in Pregnancy
Preeclampsia
Other: Neevo® (a medical food)
Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Neevo® and Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy (N-001)

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm #1 (Test group)
50 subjects administered Neevo® or Neevo®DHA daily
Other: Neevo® (a medical food)
Arm #2 (Control group)
50 subjects administered a prenatal vitamin daily
Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant Women Who Received Neevo®/Neevo® DHA or Another Standard Prenatal Vitamin

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062958

Locations
United States, Alabama
Women's Clinic Shoals
Sheffield, Alabama, United States, 35660
United States, Mississippi
Women's Health Associates
Flowood, Mississippi, United States, 39232
United States, Texas
Gainesville Obstetrics & Gynecology
Gainesville, Texas, United States, 76240
Sponsors and Collaborators
Pamlab, Inc.
Baylor Health Care System
Women's Clinic Shoals
Gainesville Obstetrics & Gynecology
Womens Health Associates
Investigators
Principal Investigator: Susan Bentley, CRNP Women's Clinic Shoals
  More Information

Publications:
Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01062958     History of Changes
Other Study ID Numbers: N-001
Study First Received: February 3, 2010
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pamlab, Inc.:
Neevo
Neevo DHA
L-methylfolate
anemia during pregnancy
folic acid
vitamin B12
prenatal vitamins
hemoglobin
iron deficiency
Pregnancy

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Anemia
Pre-Eclampsia
Hematologic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vitamins
Vitamin B 12
Hydroxocobalamin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014