A Phase 4 interventional study of 1,25-Dihydroxyvitamin D and Placebo in Non-alcoholic Fatty Liver Disease and Vitamin D Deficiency, sponsored by University Hospital Rijeka. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by University Hospital Rijeka · Phase 4, Interventional, and Treatment
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.
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 360 is above the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →University Hospital Rijeka is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Intervention drug, containing 1,25-dihydroxy-vitamin D, comes in original packages as vials containing a total amount of 10 ml of clear solution. 5 drops accounting for 1000 IU of 1,25-dihydroxy-vitamin D will be administered orally on a daily basis.
Drug: 1,25-Dihydroxyvitamin D
A placebo identical to the study intervention drug in all its characteristics (package, visual characteristics of the fluid, smell, and taste) will be administered in the same manner.
Drug: Placebo
1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months
Also known as: 1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D3
Placebo identical to the study intervention drug
Elastographic parameter of steatosis
Change of elastographic parameter of steatosis (Controlled Attenuation Parameter; CAP) during the 6 and 12 months period
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Elastographic parameter of fibrosis
Change of elastographic parameter of fibrosis (liver stiffness measurements; LSM) during the 6 and 12 months period
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Aspartate transaminase
Change in liver enzyme aspartate transaminase (AST) serum levels in the period of 6 and 12 months. Normal range = 11-38 IU/L.
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Alanine transaminase
Change in liver enzyme alanine transaminase (ALT) serum levels in the period of 6 and 12 months. Normal range = 12-48 IU/L.
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Gamma-glutamyl transferase
Change in liver enzyme gamma-glutamyl transferase (GGT) serum levels in the period of 6 and 12 months. Normal range = 11-55 IU/L.
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Insuline Resistance
Change in insulin resistance defined by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; normal range = 0.5 to 1.4) score in the period of 6 and 12 months
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Total cholesterol
Change in total cholesterol serum levels in the period of 6 and 12 months
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Low-density lipoprotein
Change in low-density lipoprotein (LDL) serum levels in the period of 6 and 12 months
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
High-density lipoprotein
Change in high-density lipoprotein (HDL) serum levels in the period of 6 and 12 months
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Triglyceride
Change in triglyceride (TG) serum levels in the period of 6 and 12 months
Time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
No study locations are listed for this record.
Plan to share: No
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →
University Hospital Rijeka