Effect on Liver Histology of Vitamin D in Patients With Non-alcoholic Steatohepatitis
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|ClinicalTrials.gov Identifier: NCT01623024|
Recruitment Status : Unknown
Verified June 2012 by Antonio Craxi, University of Palermo.
Recruitment status was: Not yet recruiting
First Posted : June 19, 2012
Last Update Posted : June 21, 2012
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 an inverse relation between vitamin D levels and the severity of liver disease. In keeping with the above data, recent experimental evidence also suggested the potential ability of vitamin D, through interaction with its nuclear receptor (vitamin D receptor - VDR), to interfere with inflammatory response, T cell function and fibrogenesis. Therefore considering the link between vitamin D serum levels, severity of NAFLD, and risk factors for NAFLD, we speculate that vitamin D might represent a new therapeutic target in the management of NASH patients.
|Condition or disease||Intervention/treatment||Phase|
|Non.Alcoholic Fatty Liver Disease||Drug: Vitamin D Behavioral: Lifestyle counseling||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
U.S. FDA Resources
|Experimental: Vitamin D and Lifestyle counseling||
Drug: Vitamin D
20.000 UI/week for 96 weeks
|Active Comparator: Lifestyle counseling||
Behavioral: Lifestyle counseling
Lifestyle counseling for 96 weeks
- (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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623024
|Contact: Antonio Craxì, MDemail@example.com|
|Sezione di Gastroenterologia, Di.Bi.M.I.S. AOUP Paolo Giaccone, University of Palermo, Italy||Not yet recruiting|
|Palermo, Italy, 90127|
|Contact: Antonio Craxì, Professor 00390916552280 firstname.lastname@example.org|
|Principal Investigator: Antonio Craxì, Professor|
|Principal Investigator:||Antonio Craxì, Professor||Sezione di Gastroenterologia, Di.Bi.M.I.S. University of PALERMO, ITALY|