Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)

This study has been terminated.
(Insufficient number of participants)
Sponsor:
Collaborator:
InfoMedics, Inc.
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT01358552
First received: May 18, 2011
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

This is an observational study in which patients who have been prescribed Néevo®/NéevoDHA® are invited to participate in surveys about their pregnancy and experiences with Néevo®/NéevoDHA®. The purpose of this study is to increase the understanding of the role of L-methylfolate among patients who are candidates for Néevo®/NéevoDHA®, provide patients with personalized education and support during their pregnancies, and contribute to the overall understanding of the needs and concerns of women facing intermediate- to high-risk pregnancies.


Condition Intervention
Pregnancy
Other: Néevo®/ NéevoDHA®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a "real world" setting.


Secondary Outcome Measures:
  • To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Néevo®/NéevoDHA®
Subjects who have been prescribed Néevo/NéevoDHA® daily.
Other: Néevo®/ NéevoDHA®
Néevo®/NéevoDHA® is an orally administered medical food indicated for the dietary management of impaired metabolic processes in women under a doctor's care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid. Néevo®/ NéevoDHA® contains L-methylfolate, the biologically active and immediately bioavailable form of folate.

Detailed Description:

Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Néevo®/NéevoDHA® has been prescribed and provide them with a patient brochure containing an introduction to the program and instructions on how to enroll. Patients interested in participating self-enroll, take a brief survey before starting their Néevo®/NéevoDHA® prescription, and then a follow-up survey 4 weeks after they have started taking Néevo®/NéevoDHA®. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Néevo®/NéevoDHA® as directed. Patients will also receive educational materials about diet and nutrition during pregnancy.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women who have been prescribed Néevo®/ NéevoDHA®

Criteria

Inclusion Criteria:

  • New Néevo®/NéevoDHA® Start.
  • Only for women who are pregnant and taking brand name Néevo®/ NéevoDHA® under a physicians care.

Exclusion Criteria:

  • Patients who are not pregnant.
  • If participant indicates that she did not get a prescription for Néevo®/ NéevoDHA®, she will not be able to complete the survey(s).
  • For the follow-up survey, if the participant indicates that she has not been taking Néevo®/NéevoDHA®, she will not be able to complete the survey( (s).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358552

Locations
United States, Texas
Noe Lira, M.D.
Corpus Christi, Texas, United States, 78411
Sponsors and Collaborators
Pamlab, Inc.
InfoMedics, Inc.
Investigators
Principal Investigator: Noe Lira, M.D. Noe Lira, M.D.
  More Information

No publications provided

Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01358552     History of Changes
Other Study ID Numbers: N-003
Study First Received: May 18, 2011
Last Updated: April 30, 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

ClinicalTrials.gov processed this record on October 01, 2014