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

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ClinicalTrials.gov Identifier: NCT01193192
Recruitment Status : Terminated (Inadequate number of charts available for Test Group)
First Posted : September 1, 2010
Last Update Posted : November 23, 2011
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. )

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Anemia in Pregnancy Pre-eclampsia Other: Neevo® Other: Prenatal vitamins

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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 :
  1. 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. ]
    To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean change in hemoglobin levels in pregnant women.

  2. 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. ]
    To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer incidences of anemia than with standard prenatal vitamins.

  3. 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. ]
    To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer cases of pre-eclampsia than with standard prenatal vitamins.

  4. 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. ]
    To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on infant birth weight.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193192


Locations
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United States, Oklahoma
Five Oaks Medical Group
Chickasha, Oklahoma, United States, 73018
Norman Regional Health System
Norman, Oklahoma, United States, 73071
Norman Regional Health System
Norman, Oklahoma, United States, 73072
Sponsors and Collaborators
Pamlab, L.L.C.
Baylor Health Care System
Norman Regional Health System
Five Oaks Medical Group
Investigators
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Principal Investigator: Nicole Jarvis, M.D. Norman Regional Health System
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pamlab, L.L.C.
ClinicalTrials.gov Identifier: NCT01193192    
Other Study ID Numbers: N-002
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011
Keywords provided by Pamlab, Inc. ( Pamlab, L.L.C. ):
Neevo
Neevo DHA
L-methylfolate
anemia during pregnancy
folic acid
 vitamin B12
prenatal vitamins
hemoglobin
iron deficiency
Pregnancy
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Anemia
Hematologic Diseases
Hypertension, Pregnancy-Induced
 Pregnancy Complications
Vitamins
Micronutrients
Physiological Effects of Drugs