Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
This trial is active, not recruiting.
|Conditions||epilepsy, psychiatric or mood diseases or conditions|
|Sponsor||North Shore Long Island Jewish Health System|
|Start date||October 2010|
|End date||April 2013|
|Trial size||200 participants|
|Trial identifier||NCT01231646, 10-266A|
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.
|Observational model||case control|
To examine association between levels of folate receptor autoantibodies and therapy (VPA, LTG) in women
time frame: n/a (cross-sectional study)
Female participants from 18 years up to 50 years old.
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.
|Official title||Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?|
|Principal investigator||Cynthia Harden, MD|
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