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

NCT01062958 | Completed

• 1 other identifier: N-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Anemia in Pregnancy; Preeclampsia

Keywords

Neevo; Neevo DHA; L-methylfolate; anemia during pregnancy; folic acid; vitamin B12; prenatal vitamins; hemoglobin; iron deficiency; Pregnancy

Outcome Measures

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.

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (2)

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)

Interventions

Neevo® (a medical food) OTHER

Arm #1 (Test group)

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

Arm #2 (Control group)

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamlab, Inc.: lead
• Baylor Health Care System: collaborator
• Women's Clinic Shoals: collaborator
• Gainesville Obstetrics & Gynecology: collaborator
• Womens Health Associates: collaborator

Study Sites (3)

Women's Clinic Shoals

Sheffield, Alabama, 35660, United States

Location

Women's Health Associates

Flowood, Mississippi, 39232, United States

Location

Gainesville Obstetrics & Gynecology

Gainesville, Texas, 76240, United States

Location

Related Publications (1)

• 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.

  PMID: 21440300 RESULT

MeSH Terms

Conditions

Pre-Eclampsia; Iron Deficiencies

Interventions

Prenatal Care; Folic Acid; Iron; Vitamin B 12

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Susan Bentley, CRNP

  Women's Clinic Shoals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

US (3)