Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Psychiatric or Mood Diseases or Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

North Shore Long Island Jewish Health System

Great Neck, New York, 11021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention. This is a cross-sectional study.

Primary outcomes

Levels of Folate Receptor Autoantibodies

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

Epilepsy Foundation

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2015
First posted: Nov 1, 2010
Registry last updated: Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed