Vitamin D Deficiency Clinical Trial
Official title:
Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography
This study evaluates the influence of vitamin D in reducing laboratory, elastographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive vitamin D (Plivit D3) while the other half will receive placebo
In this study will participate patients who come to the regular ambulatory examinations
(referred by gastroenterologists, or family physicians in the Department of Gastroenterology
CHC Rijeka) and have one or more components of the metabolic syndrome (hypertension,
diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by
transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP)
for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis.
In all patients other causes of chronic liver disease will be excluded; chronic viral
hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs
than can cause liver steatosis and fibrosis and alcoholic liver disease.
This study will include 450 patients. Taking into account the possible drop-out rate around
15% of the patients during the study period, a total of 400 patients will be randomized.
Patients will be randomized into two groups. The first group will be consisted of the
patients with NAFLD who will be receiving original medication during the 12 month period. The
second group will be consisted of the patients with NAFLD who will be receiving placebo
during the 12 months period, which will be identical to the original medication in its
packaging and form.
After the 6 and 12 months of therapy in all patients will be evaluated: liver enzymes and
metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose),
as well as the TE-CAP in order to evaluate the efficiency of Plivit D3 for the treatment of
NAFLD.
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