A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
NCT ID: NCT01193192
Last Updated: 2011-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
30 participants
OBSERVATIONAL
2010-07-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Arm #1 (Test Group)
100 subject administered Neevo® or NeevoDHA® daily
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
Prenatal vitamins
for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12.
Interventions
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Neevo®
A prenatal "medical food" - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid
Prenatal vitamins
for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
39 Years
FEMALE
Yes
Sponsors
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Baylor Health Care System
OTHER
Norman Regional Health System
UNKNOWN
Five Oaks Medical Group
UNKNOWN
Pamlab, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicole Jarvis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Norman Regional Health System
Locations
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Five Oaks Medical Group
Chickasha, Oklahoma, United States
Norman Regional Health System
Norman, Oklahoma, United States
Norman Regional Health System
Norman, Oklahoma, United States
Countries
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References
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Bentley S, Hermes A, Phillips D, Daoud YA, Hanna S. Comparative effectiveness of a prenatal medical food to prenatal vitamins on hemoglobin levels and adverse outcomes: a retrospective analysis. Clin Ther. 2011 Feb;33(2):204-10. doi: 10.1016/j.clinthera.2011.02.010. Epub 2011 Mar 25.
Other Identifiers
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N-002
Identifier Type: -
Identifier Source: org_study_id