- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463735
Vitamin E Supplement in Patients With Cirrhosis and Acanthocytosis
Study Overview
Status
Conditions
Intervention / Treatment
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 cirrhosis includes alterations in synthetic function as well as an increase in serum bilirubin. Liver diseases are also associated with hematologic complications and altered red blood cells morphology. Up to 70% of cirrhotic patients display anemia and hemoglobin level may fall to below 5 gr/L in spur cell anemia. Thrombocytopenia, leucopenia and neutropenia are also common. In patients with cirrhosis, acanthocytes and echinocytes are reported. 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 20 to 30% of red blood cells. The spiky morphology of acanthocytes results from an abnormal surface area to volume ratio and an altered membrane lipids composition. These changes in red blood cell membranes render the cell more prone to destruction and hemolysis. The true incidence of spur cells in cirrhosis is not known precisely but may avoisinate 45%, typically in patients with advanced cirrhosis.The presence of spur cells usually predicts lower survival rates. The liver is a very susceptible organ to oxidative-related cellular damage, and low antioxidants, such as vitamin E, in cirrhosis participate in cellular membrane alterations. Vitamin E is an antioxidant compound that is a component of biological membrane that helps to maintain integrity of lipid bilayers. Vitamin E deficiency leads to erythrocyte hemolysis, which is improved by supplemental vitamin E. Tocofersolan (Vedrop) is a water-soluble derivative of alpha-tocopherol, and thus an orally bio-available source of vitamin E. Vitamin E supplementation appears safe in liver diseases and provides histological benefit in NASH.
Aim and endpoints I. To determine the effect of tocofersolan on red blood cell membranes lipid composition in adult patients with cirrhosis and vitamine E deficiency II. To determine the effect of vit E on anemia, hemolysis and acanthocytosis; on lipid peroxidation and oxidative stress; the safety of a 4 week treatment of 700 mg/day
Duration: selection period: 1 week; active treatment: 4 weeks; follow-up period. 3 weeks. Evaluation time-points: baseline and after 4 weeks of treatment Methodology/Design: phase II pilot trial on 27 patients, single arm study
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Geneva 14, Switzerland, 1211
- University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C/P (cholesterol to phospholipid) ratio of erythrocyte membrane before and after tocofersolan
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percentage of acanthocytes in peripheral blood before and after tocofersolan
Time Frame: 8 weeks
|
8 weeks
|
plasma levels of vit E before and after tocofersolan
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER 10-099
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Clinical Trials on Cirrhosis
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Northwestern UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
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-
Milton S. Hershey Medical CenterNot yet recruitingCirrhosis, Liver
-
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-
The Cleveland ClinicRecruiting
-
Xin ZengRecruitingDecompensated CirrhosisChina
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