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 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2023-08-01 · Eur Rev Med Pharmacol Sci · vol. 27 · issue 16 · pp. 7607–7619
- Publisher
- National Institutes of Health
- Cited
- 27 citations · more than 96% of similar papers · 4.5× the field average
- Impact
- Top 10% most cited in its field
- References
- 0 works
- Access
- Paywalled
- Research areas
- Liver Disease Diagnosis and Treatment · Silymarin and Mushroom Poisoning · Liver Diseases and Immunity
- Keywords
- 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 authors
From SA
- Sumaiah J. AlarfajPrincess Nourah bint Abdulrahman University
- Mostafa M. Bahaa
- H A Yassin
- Eman El‐Khateeb
- Fedaa A. Kotkata
- Mahmoud A. El-Gammal
Abstract
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
Community trust
Loading…
How much do you trust this study's findings?
Comments
Sign in to rate, comment on or flag this study.Sign inSomething wrong here?
Flag this study if its information, labels or funding look wrong. An editor reviews every flag.
Sign in to rate, comment on or flag this study.Sign inEducational information about published research. Not medical advice, and not a recommendation to start or stop anything.