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
Alarfaj SJ, Bahaa MM, Yassin HA, El-Khateeb E, Kotkata FA, El-Gammal MA, Elberri AI, Habba E, Zien El-Deen EE, Khrieba MO, El-Masry TA, Negm WA, Elberri EI
European review for medical and pharmacological sciences · 15 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2023-08-01 · Eur Rev Med Pharmacol Sci · vol. 27 · número 16 · págs. 7607–7619
- Editorial
- National Institutes of Health
- Citado
- 27 citas · más que el 96% de estudios similares · 4.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 0 trabajos
- Acceso
- De pago
- Áreas de investigación
- Liver Disease Diagnosis and Treatment · Silymarin and Mushroom Poisoning · Liver Diseases and Immunity
- Palabras clave
- Internal medicine, Medicine, Fatty liver, Gastroenterology, Cholecalciferol, Malondialdehyde, Liver function, Lipid profile, Vitamin D and neurology, Quantitative insulin sensitivity check index, C-reactive protein, Endocrinology, Insulin resistance, Inflammation, Oxidative stress, Insulin, Disease, Cholesterol
- MeSH
- humans, diabetes mellitus, type 2, cholecalciferol, tumor necrosis factor-alpha, c-reactive protein, double-blind method, non-alcoholic fatty liver disease
13 autores
- Sumaiah J. Alarfaj🇸🇦Princess Nourah bint Abdulrahman University
- Mostafa M. Bahaa
- H A Yassin
- Eman El‐Khateeb
- Fedaa A. Kotkata
- Mahmoud A. El-Gammal
- AyaIbrahim Elberri
- Eslam Habba
- Esmat E Zien El-Deen
- Mohannad O Khrieba
- T A El-Masry
- Walaa A. Negm
- Eman I. El-Berri
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
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