NCT01231646CompletedNot Applicable
Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwell Health
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Levels of Folate Receptor Autoantibodies
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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