Status:
COMPLETED
Valproic Acid-associated Hypoalbuminemia in Medically Fragile Patients
Lead Sponsor:
Akron Children's Hospital
Conditions:
Hypoalbuminemia
Eligibility:
All Genders
Brief Summary
The purpose of this study is to investigate potential mechanisms of valproic acid-associated low serum albumin in medically fragile pediatric and young adult epileptic patients of a long-term care fac...
Detailed Description
Valproic acid (VPA) is a long-chain fatty acid frequently used as an antiepileptic agent in pediatric and adult seizure patients. Other adverse effects that have been associated with VPA use include h...
Eligibility Criteria
Inclusion
- Resident of Hattie Larlham long-term care facility receiving VPA for \> 3 months at the start of the study
- Resident of Hattie Larlham long-term care facility matched to a resident receiving VPA for \> 3 month based on concomitant AED, length of time on AED, age, and gender
- Resident of Hattie Larlham long-term care facility not receiving AED matched to a resident receiving VPA for \> 3 month based on age and gender
Exclusion
- Received albumin products within the past 1 month
- Receiving VPA for \< 3 months or discontinuation of VPA therapy within the past four weeks
- Medical need for specific protein supplementation
- Diagnosed with protein-losing nephropathy or enteropathy
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00723762
Start Date
February 1 2009
End Date
December 1 2010
Last Update
March 10 2011
Active Locations (1)
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1
Hattie Larlham Center for Children with Disabilities
Mantua, Ohio, United States, 44255