Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT06031532
Collaborator
(none)
110
1
3
36.4

Study Details

Study Description

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) has become the most common liver disease at a global scale and is strongly associated with the obesity and metabolic syndrome . It is recognized as a hepatic manifestation of the metabolic syndrome, and characterized by lipid infiltration in the hepatocytes. NAFLD comprises a range of diseases from simple steatosis to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and may progress to hepatocellular carcinoma (HCC) .

The worldwide prevalence of NAFLD is estimated to be 24% while it is reported to have much higher incidence in patients with metabolic syndrome and type 2 diabetes (T2D) (5). The mortality rate and the number of liver transplantations owing to NAFLD and NASH are increasing, making it the second leading cause of liver transplant in the United States .

Tow significant metabolic abnormalities commonly linked to NAFLD are insulin resistance (IR) and increased supply of fatty acids to the liver . Chronic liver diseases (CLD), including NAFLD, are commonly associated with nutrient and vitamins deficiencies such as those of vitamins D and A (8,9).

Almost all studies documenting vitamin A status in metabolic syndrome (MetS) report reductions in serum retinol, retinoic acid, and/or β-carotene that are inversely correlated with MetS features, including obesity, insulin resistance, glucose intolerance, and hypertriglyceridemia . In line with these observations, inadequate serum retinol levels (<1.05 μmol/L) were found in 11-36% of morbidly obese adults with ultrasonography-proven NAFLD, and a significant association between low retinol levels and insulin resistance (IR) was found . Moreover, serum retinol levels were inversely associated with body mass and serum transaminases in patients with NAFLD, suggesting a link between retinol inadequacy and development of disease.

The liver plays a critical role in lipid metabolism by taking up serum free fatty acids (FFA) that are involved in the synthesis, storage, and transport of lipid metabolites. The accumulation of excess triacylglycerol (TG) within the liver due to the entry of excess FFA from the obese adipose tissue due to increased lipolysis leads to the development of non-alcoholic fatty liver diseases (NAFLD) .

Study Design

Study Type:
Observational
Actual Enrollment :
110 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease
Actual Study Start Date :
May 1, 2023
Actual Primary Completion Date :
Aug 1, 2023
Actual Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
cases group

Non-alcoholic fatty liver patients

control group

healthy persons

Outcome Measures

Primary Outcome Measures

  1. level Vitamin A and Calcium in serum of Patients With Non-alcoholic Fatty Liver patients [2 months]

    Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease

  2. fibroscan ultrasound to Non-alcoholic Fatty Liver patients [2 months]

    fibroscan measures to Non-alcoholic Fatty Liver patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • NAFLD patients
Exclusion Criteria:
  • • Chronic viral hepatitis or other chronic liver diseases.

  • Hepatocellular carcinoma or other malignancies.

  • Chemotherapy or radiotherapy within the last three months.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt Sohag

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zainab Mahmoud Kadry, lecturer of medical biochemistry, Sohag University
ClinicalTrials.gov Identifier:
NCT06031532
Other Study ID Numbers:
  • Soh-Med-23-04-25PD
First Posted:
Sep 11, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2023