Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

Completed

• Conditions: Epilepsy; Psychiatric or Mood Diseases or Conditions
• Interventions: Other: No intervention

• Registration Number: NCT01231646
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-11-01
• Primary Completion: 2013-04
• Study Completion: 2015-07
• Results First Submitted: 2015-08-24
• Results First Submitted QC: 2015-09-23
• Status Verified: 2015-10
• Results First Posted: 2015-10-23
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• 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.

Exclusion Criteria

• Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lamotrigine	No intervention	No intervention
Valproate	No intervention	No intervention

Primary Outcome Measures

Name	Time	Method
Levels of Folate Receptor Autoantibodies	On the same day after informed consent was obtained	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.

Trial Locations

Locations (1)

North Shore Long Island Jewish Health System; 🇺🇸 Great Neck, New York, United States