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

NCT01358552 | Terminated

• 1 other identifier: N-003
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Neevo; Neevo DHA; L-methylfolate; anemia during pregnancy; folic acid; vitamin B12; prenatal vitamins; hemoglobin; iron deficiency; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale

  Week 4

Study Arms (1)

Néevo®/NéevoDHA®

Subjects who have been prescribed Néevo/NéevoDHA® daily.

Other: Néevo®/ NéevoDHA®

Interventions

Néevo®/ NéevoDHA® OTHER

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.

Néevo®/NéevoDHA®

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women who have been prescribed Néevo®/ NéevoDHA®

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pamlab, Inc.: lead
• InfoMedics, Inc.: collaborator

Study Sites (1)

Noe Lira, M.D.

Corpus Christi, Texas, 78411, United States

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Noe Lira, M.D.

  Noe Lira, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 23, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

US (1)