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

This study has been terminated.
(Inadequate number of charts available for Test Group)
Sponsor:
Collaborators:
Baylor Health Care System
Norman Regional Health System
Five Oaks Medical Group
Information provided by (Responsible Party):
Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier:
NCT01193192
First received: August 30, 2010
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Anemia in Pregnancy
Pre-eclampsia
Other: Neevo®
Other: Prenatal vitamins

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

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • Mean Hemoglobin (Hgb) Levels [ Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. ] [ Designated as safety issue: No ]
    To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy.


Secondary Outcome Measures:
  • Mean Change in Hemoglobin (Hgb) Levels [ Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. ] [ Designated as safety issue: No ]
    To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean change in hemoglobin levels in pregnant women.

  • Incidence of Anemia [ Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. ] [ Designated as safety issue: No ]
    To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer incidences of anemia than with standard prenatal vitamins.

  • Incidence of Pre-eclampsia [ Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. ] [ Designated as safety issue: No ]
    To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer cases of pre-eclampsia than with standard prenatal vitamins.

  • Mean Infant Birth Rate [ Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. ] [ Designated as safety issue: No ]
    To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on infant birth weight.


Enrollment: 30
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm #1 (Test Group)
100 subject administered Neevo® or NeevoDHA® daily
Other: Neevo®
A prenatal "medical food" - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid
Arm #2 (Control group)
100 subject administered a prenatal vitamin daily
Other: Prenatal vitamins
for inclusion in the Control Group, prenatal vitamins must have contained ≤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®/NeevoDHA® or Another Standard Prenatal Vitamin

Criteria

Inclusion Criteria:

  • 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

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 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
  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: NCT01193192

Locations
United States, Oklahoma
Five Oaks Medical Group
Chickasha, Oklahoma, United States, 73018
Norman Regional Health System
Norman, Oklahoma, United States, 73072
Norman Regional Health System
Norman, Oklahoma, United States, 73071
Sponsors and Collaborators
Pamlab, L.L.C.
Baylor Health Care System
Norman Regional Health System
Five Oaks Medical Group
Investigators
Principal Investigator: Nicole Jarvis, M.D. Norman Regional Health System
  More Information

No publications provided by Pamlab, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier: NCT01193192     History of Changes
Other Study ID Numbers: N-002
Study First Received: August 30, 2010
Last Updated: November 22, 2011
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:
Anemia
Eclampsia
Pre-Eclampsia
Hematologic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014