A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
This study has been completed.
Sponsor:
Pamlab, Inc.
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
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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
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:
|
Anemia Pre-Eclampsia Hematologic Diseases Hypertension, Pregnancy-Induced Pregnancy Complications Folic Acid Vitamin B Complex Vitamin B 12 Hydroxocobalamin |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013