Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-31 @ 8:09 PM
Study NCT ID:
NCT01062958
Status:
COMPLETED
Last Update Posted:
2013-04-16
First Post:
2010-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011295', 'term': 'Prenatal Care'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D007501', 'term': 'Iron'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008427', 'term': 'Maternal Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2010-02-03', 'studyFirstSubmitQcDate': '2010-02-03', 'lastUpdatePostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.'}], 'secondaryOutcomes': [{'measure': 'To determine the effect of Neevo®/Neevo®DHA versus standard prenatal vitamins on red blood cell (RBC) levels in pregnant women.', 'timeFrame': 'At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.'}, {'measure': 'To determine if Neevo®/Neevo®DHA administration during pregnancy results in fewer anemias than with standard prenatal vitamins.', 'timeFrame': 'At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neevo', 'Neevo DHA', 'L-methylfolate', 'anemia during pregnancy', 'folic acid', 'vitamin B12', 'prenatal vitamins', 'hemoglobin', 'iron deficiency', 'Pregnancy'], 'conditions': ['Anemia in Pregnancy', 'Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '21440300', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant Women Who Received Neevo®/Neevo® DHA or Another Standard Prenatal Vitamin', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n* 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.\n* Subjects must have been compliant in taking Neevo DHA or other prenatal vitamin.\n\nExclusion Criteria:\n\n* Subjects should not have taken Prenate®, Prenate®DHA, or Prenate® Elite, which are L-methylfolate-containing prenatal vitamins.\n* 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®.\n* History of any anemia other than iron deficiency anemia or leukemia.\n* Blood transfusion in the 4 months prior to diagnosis of pregnancy.'}, 'identificationModule': {'nctId': 'NCT01062958', 'briefTitle': 'A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pamlab, Inc.'}, 'officialTitle': 'A Retrospective Analysis of Neevo® and Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy (N-001)', 'orgStudyIdInfo': {'id': 'N-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm #1 (Test group)', 'description': '50 subjects administered Neevo® or Neevo®DHA daily', 'interventionNames': ['Other: Neevo® (a medical food)']}, {'label': 'Arm #2 (Control group)', 'description': '50 subjects administered a prenatal vitamin daily', 'interventionNames': ['Other: Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)']}], 'interventions': [{'name': 'Neevo® (a medical food)', 'type': 'OTHER', 'armGroupLabels': ['Arm #1 (Test group)']}, {'name': 'Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)', 'type': 'OTHER', 'armGroupLabels': ['Arm #2 (Control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': "Women's Clinic Shoals", 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': "Women's Health Associates", 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '76240', 'city': 'Gainesville', 'state': 'Texas', 'country': 'United States', 'facility': 'Gainesville Obstetrics & Gynecology', 'geoPoint': {'lat': 33.62594, 'lon': -97.13335}}], 'overallOfficials': [{'name': 'Susan Bentley, CRNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's Clinic Shoals"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamlab, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baylor Health Care System', 'class': 'OTHER'}, {'name': "Women's Clinic Shoals", 'class': 'UNKNOWN'}, {'name': 'Gainesville Obstetrics & Gynecology', 'class': 'OTHER'}, {'name': 'Womens Health Associates', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}