NCT01358552

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Pamlab, Inc. · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-05-23
• Last updated: 2013-05-01

Locations

1 site across 1 country: United States