Valproic Acid-associated Hypoalbuminemia in Medically Fragile Patients
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|ClinicalTrials.gov Identifier: NCT00723762|
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : March 10, 2011
|Condition or disease||Intervention/treatment|
|Hypoalbuminemia||Procedure: Specimen collection|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Observational Model:||Case Control|
|Official Title:||Valproic Acid-associated Hypoalbuminemia in Medically Fragile Pediatric and Young Adult Patients in a Long Term Care Facility Part 1: Potential Mechanism for Decreased Albumin Synthesis|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2010|
Resident of Hattie Larlham long-term care facility receiving VPA
Procedure: Specimen collection
A blood sample and a spot urine sample will be obtained from all eligible patients receiving VPA at the start of the study.
Control AED patients will be recruited based on similar AED regimens excluding VPA, length of time on AED (number of months to >1 year), age, and gender; one control patient per VPA patient.
Control non-AED patients will be recruited based on age and gender; one control patient per VPA patient.
- The primary outcome will be serum albumin concentrations at baseline in the patients receiving VPA. [ Time Frame: Baseline ]
- Secondary outcome variables will include serum amino acid concentrations, total protein, AST, ALT, alkaline phosphatase, ammonia, BUN, and sCr and urine albumin, protein, and urea. [ Time Frame: Baseline ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723762
|United States, Ohio|
|Hattie Larlham Center for Children with Disabilities|
|Mantua, Ohio, United States, 44255|
|Principal Investigator:||Michael Reed, PharmD||Akron Children's Hospital Research Center|
|Study Chair:||Martha Blackford, PharmD||Akron Children's Hospital|
|Study Chair:||Richard Grossberg, MD||Hattie Larlham|