Vitamin E Supplement in Patients With Cirrhosis and Acanthocytosis

NCT01463735 | Completed Phase 2

• 1 other identifier: CER 10-099
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 20 to 30% of red blood cells. Up to 70% of cirrhotic patients display anemia and hemoglobin level may fall to below 5 gr/L in spur cell anemia. 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. 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. This study is an open label single arm phase II study in cirrhotic patients treated for 4 weeks with Tocofersolan (Vedrop), a water-soluble derivative of alpha-tocopherol, and thus an orally bio-available source of vitamin E. The aim of this study is to determine the effect of tocofersolan on red blood cell membranes lipid composition in adult patients with cirrhosis and vitamin E deficiency. Secondary endpoints are the effects of tocofersolan on anemia, hemolysis and acanthocytosis; on lipid peroxidation and oxidative stress; the safety of a 4 week treatment of 700 mg/day.

Conditions

Cirrhosis

Keywords

Cirrhotic patients

Outcome Measures

Primary Outcomes (1)

• C/P (cholesterol to phospholipid) ratio of erythrocyte membrane before and after tocofersolan

  8 weeks

Secondary Outcomes (2)

• percentage of acanthocytes in peripheral blood before and after tocofersolan

  8 weeks

• plasma levels of vit E before and after tocofersolan

  8 weeks

Interventions

Vitamin E supplement (tocofersolan) DIETARY_SUPPLEMENT

700 mg per day per os (i.e. 350 mg twice a day with meals)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any other severe condition affecting interfering with the normal conduct of the study
• Already participating in another clinical study

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Fibrosis

Interventions

tocophersolan

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 2, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

CH (1)