Valproic Acid-associated Hypoalbuminemia in Medically Fragile Patients

NCT00723762 | Completed

• 1 other identifier: Valproic Acid-Albumin
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 facility.

Conditions

Hypoalbuminemia

Keywords

Valproic acid; Urea cycle; Ornithine; Valproate; Side effect

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be serum albumin concentrations at baseline in the patients receiving VPA.

  Baseline

Secondary Outcomes (1)

• 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.

  Baseline

Study Arms (3)

1

Resident of Hattie Larlham long-term care facility receiving VPA

Procedure: Specimen collection

2

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.

3

Control non-AED patients will be recruited based on age and gender; one control patient per VPA patient.

Interventions

Specimen collection PROCEDURE

A blood sample and a spot urine sample will be obtained from all eligible patients receiving VPA at the start of the study.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medically fragile residents of the Hattie Larlham Long Term Care Facilit.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Hattie Larlham Center for Children with Disabilities

Mantua, Ohio, 44255, United States

Location

Related Publications (6)

• Attilakos A, Voudris KA, Katsarou E, Prassouli A, Mastroyianni S, Garoufi A. Transient decrease in serum albumin concentrations in epileptic children treated with sodium valproate monotherapy. Clin Neuropharmacol. 2007 May-Jun;30(3):145-9. doi: 10.1097/wnf.0b013e3180318a99.

  PMID: 17545749 BACKGROUND

• Hauser E, Seidl R, Freilinger M, Male C, Herkner K. Hematologic manifestations and impaired liver synthetic function during valproate monotherapy. Brain Dev. 1996 Mar-Apr;18(2):105-9. doi: 10.1016/0387-7604(95)00139-5.

  PMID: 8733899 BACKGROUND

• Rugino TA, Janvier YM, Baunach JM, Bilat CA. Hypoalbuminemia with valproic acid administration. Pediatr Neurol. 2003 Nov;29(5):440-4. doi: 10.1016/s0887-8994(03)00310-2.

  PMID: 14684241 BACKGROUND

• Oratz M, Rothschild MA, Schreiber SS, Burks A, Mongelli J, Matarese B. The role of the urea cycle and polyamines in albumin synthesis. Hepatology. 1983 Jul-Aug;3(4):567-71. doi: 10.1002/hep.1840030415.

  PMID: 6407956 BACKGROUND

• Karikas GA, Schulpis KH, Bartzeliotou A, Karakonstantakis T, Georgala S, Kanavaki I, Demetriou E, Papassotiriou I. Lipids, lipoproteins, apolipoproteins, selected trace elements and minerals in the serum of children on valproic acid monotherapy. Basic Clin Pharmacol Toxicol. 2006 Jun;98(6):599-603. doi: 10.1111/j.1742-7843.2006.pto_402.x.

  PMID: 16700824 BACKGROUND

• Castro-Gago M, Rodrigo-Saez E, Novo-Rodriguez I, Camina MF, Rodriguez-Segade S. Hyperaminoacidemia in epileptic children treated with valproic acid. Childs Nerv Syst. 1990 Dec;6(8):434-6. doi: 10.1007/BF00302087.

  PMID: 2095300 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples from patients receiving VPA.

MeSH Terms

Conditions

Hypoalbuminemia

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Michael Reed, PharmD

  Akron Children's Hospital Research Center

  PRINCIPAL INVESTIGATOR

• Martha Blackford, PharmD

  Akron Children's Hospital

  STUDY CHAIR

• Richard Grossberg, MD

  Hattie Larlham

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 10, 2011

Record last verified: 2011-03

Locations

US (1)