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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01358552
• Other study ID #: N-003
• Status: Terminated
• Phase: N/A
• First received: May 18, 2011
• Last updated: April 30, 2013
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Noe Lira, M.D.	Corpus Christi	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Pamlab, Inc.	InfoMedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance	To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a "real world" setting.	Week 4	No
Secondary	To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale		Week 4	No