Status:
COMPLETED
Vitamin E Supplement in Patients With Cirrhosis and Acanthocytosis
Lead Sponsor:
University Hospital, Geneva
Conditions:
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Acanthocytes, also termed spur cell, are large erythrocytes covered with spike-like projections which are associated with severe hemolytic anemia. In advanced cirrhosis, acanthocytes may account for 2...
Detailed Description
Background: Cirrhosis may be complicated by the presence of ascites, portosystemic collaterals that may eventually bleed or give rise to hepatic encephalopathy. Laboratory findings in patients with c...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Cirrhosis (histology or, if not available, based on clinical, biological and radiological findings)
- Total bilirubin \> 60 µmol/ L
- Anemia defined as hemoglobin \< 120 g/L
- Vitamin E deficiency as defined by plasma levels \< 23 µmol/L
Exclusion
- Inability or unwillingness to give written consent
- Parenteral nutrition
- Co-medication with Orlistat, Colestipol, anticoagulants
- Active alcohol consumption as assessed by urine analysis
- Gastro-intestinal bleeding within the past 2 weeks
- Gastric bypass
- Moderate to severe renal failure as defined by creatinine clearance \< 60 ml/min
- Hypothyroidism as defined by TSH \> 6 mU/L
- Diagnosis of cancer upon inclusion in the study
- Any other severe condition affecting interfering with the normal conduct of the study
- Already participating in another clinical study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01463735
Start Date
November 1 2011
End Date
May 1 2013
Last Update
March 18 2014
Active Locations (1)
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1
University Hospitals
Geneva, Switzerland, 1211