A randomized placebo-controlled, double-blind study to investigate the effect of a high oral loading dose of cholecalciferol in non-alcoholic fatty liver disease patients, new insights on serum STAT-3 and hepassocin.

OBJECTIVE: Non-alcoholic fatty liver disease (NAFLD) is a common chronic liver metabolic disease affecting millions globally. This study aimed to assess the safety and efficacy of a high oral loading dose of cholecalciferol supplement on NAFLD patients and to investigate its potential role on serum inflammatory biomarkers. PATIENTS AND METHODS: One hundred patients with NAFLD and type 2 diabetes mellitus were involved in the study. Eligible patients were randomized among two equal groups. Group 1 received the standard conventional therapy in addition to a placebo. Group 2 received the conventional therapy plus cholecalciferol for 4 months. The improvement in the patients' glycaemic control parameters, liver function tests, lipid profile, and serum 25-hydroxy vitamin D at the end of the study was set as a primary outcome. The secondary outcome was the decrease in steatosis grade in the ultrasound and high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), signal transducer and activator of factor-3 (STAT-3), nitric oxide (NO), malondialdehyde (MDA), and hepassocin serum levels at the end of the study. RESULTS: Group 2 revealed a significant reduction in the serum levels of lipid profile measures, hs-CRP, alanine aminotransferase (ALT), STAT-3, NO, hepassocin, and MDA compared to the baseline and group 1 results. Whereas group 1 did not show these significant changes. Both groups observed no significant changes in glycemic index, TNF-α, aspartate aminotransferase (AST), and albumin levels. CONCLUSIONS: Cholecalciferol is recommended as additional therapy to modulate lipid peroxidation and systemic inflammation alongside other NAFLD therapies.

Nitazoxanide-based therapeutic regimen as a novel treatment for Helicobacter pylori infection in children and adolescents: a randomized trial.

OBJECTIVE: Antibiotic resistance and poor patient compliance with treatment cause Helicobacter pylori to show increased resistance to typical first-line therapeutic regimens. This study aimed to evaluate the efficacy of the new nitazoxanide-based treatment regimens for Helicobacter pylori infection vs. the current metronidazole-based regimens to address the problem of increasing metronidazole resistance. PATIENTS AND METHODS: This randomized clinical trial enrolled 100 patients with Helicobacter pylori infection. The patients were randomly assigned to one of two groups: group I received nitazoxanide-based triple therapy (nitazoxanide, proton pump inhibitor, and clarithromycin) for 14 days, whereas group II received standard treatment (metronidazole, omeprazole, and clarithromycin) for 14 days. On enrollment and after six weeks of treatment, all patients underwent careful history taking, full clinical examination, laboratory investigations (complete blood count, liver and renal function tests), and Helicobacter pylori stool antigen testing. RESULTS: Of the patients, 92% in the nitazoxanide group and 84% in the metronidazole group recovered from infection, with no statistically significant difference between the two groups. Patients in the nitazoxanide group showed a 54% lower risk of resistant infection (odds ratio, 0.5; 95% confidence interval, 0.161-1.555) than those in the metronidazole group. CONCLUSIONS: The nitazoxanide-based therapeutic regimen produced higher eradication rates than the standard treatment. However, the difference was not substantial in this particular group of patients.