Effects of vitamin D supplementation on liver fibrogenic factors in non-alcoholic fatty liver patients with steatohepatitis: study protocol for a randomized clinical trial.
Adult
Biomarkers
/ blood
Circulating MicroRNA
/ blood
Dietary Supplements
/ adverse effects
Double-Blind Method
Extracellular Matrix Proteins
/ blood
Female
Humans
Iran
Liver Cirrhosis
/ blood
Male
Middle Aged
Non-alcoholic Fatty Liver Disease
/ blood
Randomized Controlled Trials as Topic
Receptors, Calcitriol
/ blood
Time Factors
Treatment Outcome
Vitamin D
/ administration & dosage
Young Adult
Fibrosis
Non-alcoholic fatty liver
Trial protocol
Vitamin D
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
04 Mar 2019
04 Mar 2019
Historique:
received:
10
09
2018
accepted:
06
02
2019
entrez:
6
3
2019
pubmed:
6
3
2019
medline:
27
6
2019
Statut:
epublish
Résumé
It has been suggested that vitamin D and its receptors involve in suppressing fibrogenic signaling in non-alcoholic fatty liver disease (NAFLD). However, the effect of vitamin D supplementation on fibrogenic factors has not been investigated in NAFLD individuals with steatohepatitis. This study was designed to examine the effects on vitamin D supplementation on serum levels of vitamin D receptor (VDR), fibrogenic factors, and fibrogenic microRNAs (MiR) in NAFLD patients. Forty-six NAFLD patients will be recruited in this study. After block matching for sex and BMI, they will be randomly assigned to receive 4000 IU/day vitamin D or placebo for 12 weeks. Weight, height, and waist circumference will be measured. Determination of serum fibrogenic MiRs, laminin, collagen type IV, hyaluronic acid, vitamin D, VDR, calcium, blood glucose, serum insulin, lipid profile, liver markers (ALT, AST, total, direct, and indirect bilirubin) will be done at study baseline and at the end of the trial. Insulin resistance and insulin sensitivity will be determined using the HOMA-IR and QUICKI equation. This is the first randomized controlled trial that will determine the effect of vitamin D supplementation on serum levels of VDR, fibrogenic factors, and fibrogenic MiRs in NAFLD patients. The results of this trial will provide clinical evidence on the effectiveness of vitamin D supplementation in controlling liver fibrosis in NAFLD patients. Iranian Registry of Clinical Trials, IRCT201405251485N13 . Registered on 14 March 2017.
Sections du résumé
BACKGROUND
BACKGROUND
It has been suggested that vitamin D and its receptors involve in suppressing fibrogenic signaling in non-alcoholic fatty liver disease (NAFLD). However, the effect of vitamin D supplementation on fibrogenic factors has not been investigated in NAFLD individuals with steatohepatitis. This study was designed to examine the effects on vitamin D supplementation on serum levels of vitamin D receptor (VDR), fibrogenic factors, and fibrogenic microRNAs (MiR) in NAFLD patients.
METHODS
METHODS
Forty-six NAFLD patients will be recruited in this study. After block matching for sex and BMI, they will be randomly assigned to receive 4000 IU/day vitamin D or placebo for 12 weeks. Weight, height, and waist circumference will be measured. Determination of serum fibrogenic MiRs, laminin, collagen type IV, hyaluronic acid, vitamin D, VDR, calcium, blood glucose, serum insulin, lipid profile, liver markers (ALT, AST, total, direct, and indirect bilirubin) will be done at study baseline and at the end of the trial. Insulin resistance and insulin sensitivity will be determined using the HOMA-IR and QUICKI equation.
DISCUSSION
CONCLUSIONS
This is the first randomized controlled trial that will determine the effect of vitamin D supplementation on serum levels of VDR, fibrogenic factors, and fibrogenic MiRs in NAFLD patients. The results of this trial will provide clinical evidence on the effectiveness of vitamin D supplementation in controlling liver fibrosis in NAFLD patients.
TRIAL REGISTRATION
BACKGROUND
Iranian Registry of Clinical Trials, IRCT201405251485N13 . Registered on 14 March 2017.
Identifiants
pubmed: 30832722
doi: 10.1186/s13063-019-3241-7
pii: 10.1186/s13063-019-3241-7
pmc: PMC6398251
doi:
Substances chimiques
Biomarkers
0
Circulating MicroRNA
0
Extracellular Matrix Proteins
0
Receptors, Calcitriol
0
VDR protein, human
0
Vitamin D
1406-16-2
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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