Clinical Trial: Effect on Liver Histology of Vitamin D in Patients With Non-alcoholic Steatohepatitis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomised Controlled Trial of Vitamin D Plus Plus Lifestyle Versus Lifestyle in Patients With Non-alcoholic Steatohepatitis:Effect on Liver Histology and Metabolic Parameters

Brief Summary:

Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of disorders characterized by predominantly macrovesicular hepatic steatosis occurring in individuals in the absence of significant alcohol consumption. In this context it is possible to distinguish a condition of simple fatty liver, where the only histologic finding is the presence of steatosis, from a state of non-alcoholic steatohepatitis (NASH), characterized by hepatocellular injury/inflammation with or without fibrosis. The prevalence of NAFLD is around 20-30% in the general population. With a rapid increase in the risk factors for metabolic syndrome, NAFLD has become the most common cause of liver disease in Western countries. The clinical relevance of NAFLD arises from the fact that a considerable proportion of subjects (20-30%) develop NASH, and this condition can progress to cirrhosis in up to 15% of patients. In addition NAFLD, and particularly NASH, represents a cardiovascular risk factor, independent of other well-known conditions contributing to heart and vascular diseases.

Lifestyle modification is the effective medical treatment recommended for NASH, while there is currently no pharmacologic therapy of proven benefit in these patients. Several pilot studies, using insulin sensitizers (thiazolidinediones or metformin), and antioxidants, like vitamin E, have provided inconclusive evidence that these drugs may improve clinical and histological features of NASH.

In the complex and not completely understood pathogenic puzzle of NAFLD and NASH, also vitamin D might have an important role. Vitamin D deficiency is associated with many common pathological conditions frequently observed in NAFLD, like cardiovascular disease, and insulin resistance. A recent paper by Targher and colleagues showed low vitamin D serum levels in NAFLD patients, identifying a

Detailed Summary:
Sponsor: University of Palermo

Current Primary Outcome: (a) improvement in NAS by at least 2 points spread across at least 2 of the NAS components or post-treatment NAS of 3 points or less, (b) at least 1 point improvement in the score for ballooning degeneration and (c) no worsening of the fibrosis score. [ Time Frame: 96 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in individual components of NAS score [ Time Frame: 96 WEEKS ]
  • Changes in intima-media thickness [ Time Frame: 96 WEEKS ]
  • Changes in liver fibrosis [ Time Frame: 96 weeks ]
  • Changes in insulin resistance [ Time Frame: 96 weeks ]


Original Secondary Outcome:

  • Changes in individual components of NAS score, in fibrosis, as well as changes in serum aminotransferase levels, anthropometric measures, visceral adiposity index (VAI), insulin resistance, lipid profiles and liver elastometry [ Time Frame: 96 WEEKS ]
  • Changes in intima-media thickness, the prevalence and severity of metabolic syndrome, the cardiovascular risk profile [ Time Frame: 96 WEEKS ]


Information By: University of Palermo

Dates:
Date Received: June 15, 2012
Date Started: September 2012
Date Completion:
Last Updated: June 20, 2012
Last Verified: June 2012