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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
History of Changes
  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:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

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
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 June 17, 2013