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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358552
Recruitment Status : Terminated (Insufficient number of participants)
First Posted : May 23, 2011
Last Update Posted : May 1, 2013
InfoMedics, Inc.
Information provided by (Responsible Party):
Pamlab, Inc.

Brief Summary:
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 or disease Intervention/treatment
Pregnancy Other: Néevo®/ NéevoDHA®

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.

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance [ Time Frame: Week 4 ]
    To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a "real world" setting.

Secondary Outcome Measures :
  1. To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale [ Time Frame: Week 4 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women who have been prescribed Néevo®/ NéevoDHA®

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01358552

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United States, Texas
Noe Lira, M.D.
Corpus Christi, Texas, United States, 78411
Sponsors and Collaborators
Pamlab, Inc.
InfoMedics, Inc.
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Principal Investigator: Noe Lira, M.D. Noe Lira, M.D.
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Responsible Party: Pamlab, Inc. Identifier: NCT01358552    
Other Study ID Numbers: N-003
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013
Keywords provided by Pamlab, Inc.:
Neevo DHA
anemia during pregnancy
folic acid
vitamin B12
prenatal vitamins
iron deficiency