Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
1 other identifier
observational
38
1 country
1
Brief Summary
Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
October 23, 2015
CompletedNovember 20, 2015
October 1, 2015
2.5 years
October 28, 2010
August 24, 2015
October 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of Folate Receptor Autoantibodies
ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.
On the same day after informed consent was obtained
Study Arms (2)
Lamotrigine
No intervention
Valproate
No intervention
Interventions
Eligibility Criteria
Patients in epilepsy and/or psychiatric clinics
You may qualify if:
- Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions
- Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded.
You may not qualify if:
- Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- Epilepsy Foundationcollaborator
Study Sites (1)
North Shore Long Island Jewish Health System
Great Neck, New York, 11021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Connie Lau, MS, CCRC
- Organization
- North Shore-LIJ Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Harden, MD
North Shore-Long Island Jewish Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
November 1, 2010
Study Start
October 1, 2010
Primary Completion
April 1, 2013
Study Completion
July 1, 2015
Last Updated
November 20, 2015
Results First Posted
October 23, 2015
Record last verified: 2015-10