xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06031532</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-04-25PD</org_study_id>
      <nct_id>NCT06031532</nct_id>
    </id_info>
    <brief_title>Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease</brief_title>
    <official_title>Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Non-alcoholic fatty liver disease (NAFLD) has become the most common liver disease at a&#xD;
        global scale and is strongly associated with the obesity and metabolic syndrome . It is&#xD;
        recognized as a hepatic manifestation of the metabolic syndrome, and characterized by lipid&#xD;
        infiltration in the hepatocytes. NAFLD comprises a range of diseases from simple steatosis to&#xD;
        non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and may progress to hepatocellular&#xD;
        carcinoma (HCC) .&#xD;
  &#xD;
        The worldwide prevalence of NAFLD is estimated to be 24% while it is reported to have much&#xD;
        higher incidence in patients with metabolic syndrome and type 2 diabetes (T2D) (5). The&#xD;
        mortality rate and the number of liver transplantations owing to NAFLD and NASH are&#xD;
        increasing, making it the second leading cause of liver transplant in the United States .&#xD;
  &#xD;
        Tow significant metabolic abnormalities commonly linked to NAFLD are insulin resistance (IR)&#xD;
        and increased supply of fatty acids to the liver . Chronic liver diseases (CLD), including&#xD;
        NAFLD, are commonly associated with nutrient and vitamins deficiencies such as those of&#xD;
        vitamins D and A (8,9).&#xD;
  &#xD;
        Almost all studies documenting vitamin A status in metabolic syndrome (MetS) report&#xD;
        reductions in serum retinol, retinoic acid, and/or β-carotene that are inversely correlated&#xD;
        with MetS features, including obesity, insulin resistance, glucose intolerance, and&#xD;
        hypertriglyceridemia . In line with these observations, inadequate serum retinol levels&#xD;
        (&lt;1.05 μmol/L) were found in 11-36% of morbidly obese adults with ultrasonography-proven&#xD;
        NAFLD, and a significant association between low retinol levels and insulin resistance (IR)&#xD;
        was found . Moreover, serum retinol levels were inversely associated with body mass and serum&#xD;
        transaminases in patients with NAFLD, suggesting a link between retinol inadequacy and&#xD;
        development of disease.&#xD;
  &#xD;
        The liver plays a critical role in lipid metabolism by taking up serum free fatty acids (FFA)&#xD;
        that are involved in the synthesis, storage, and transport of lipid metabolites. The&#xD;
        accumulation of excess triacylglycerol (TG) within the liver due to the entry of excess FFA&#xD;
        from the obese adipose tissue due to increased lipolysis leads to the development of&#xD;
        non-alcoholic fatty liver diseases (NAFLD) .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>level Vitamin A and Calcium in serum of Patients With Non-alcoholic Fatty Liver patients</measure>
      <time_frame>2 months</time_frame>
      <description>Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease</description>
    </primary_outcome>
    <primary_outcome>
      <measure>fibroscan ultrasound to Non-alcoholic Fatty Liver patients</measure>
      <time_frame>2 months</time_frame>
      <description>fibroscan measures to Non-alcoholic Fatty Liver patients</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">110</enrollment>
    <condition>Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Patients</condition>
    <arm_group>
      <arm_group_label>cases group</arm_group_label>
      <description>Non-alcoholic fatty liver patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>healthy persons</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This hospital based case control study will be conducted on 110 patients who attend to&#xD;
          Tropical Medicine and Gastroenterology outpatient clinic, Sohag University Hospital in a&#xD;
          period of 6 months. Participants will be classified into NAFLD group and control group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  NAFLD patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Chronic viral hepatitis or other chronic liver diseases.&#xD;
  &#xD;
                 -  Hepatocellular carcinoma or other malignancies.&#xD;
  &#xD;
                 -  Chemotherapy or radiotherapy within the last three months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <zip>Sohag</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Muthiah MD, Sanyal AJ. Burden of Disease due to Nonalcoholic Fatty Liver Disease. Gastroenterol Clin North Am. 2020 Mar;49(1):1-23. doi: 10.1016/j.gtc.2019.09.007.</citation>
      <PMID>32033757</PMID>
    </reference>
    <reference>
      <citation>Raza S, Rajak S, Anjum B, Sinha RA. Molecular links between non-alcoholic fatty liver disease and hepatocellular carcinoma. Hepatoma Res. 2019 Dec 11;5:42. doi: 10.20517/2394-5079.2019.014.</citation>
      <PMID>31867441</PMID>
    </reference>
    <reference>
      <citation>Younossi Z, Stepanova M, Ong JP, Jacobson IM, Bugianesi E, Duseja A, Eguchi Y, Wong VW, Negro F, Yilmaz Y, Romero-Gomez M, George J, Ahmed A, Wong R, Younossi I, Ziayee M, Afendy A; Global Nonalcoholic Steatohepatitis Council. Nonalcoholic Steatohepatitis Is the Fastest Growing Cause of Hepatocellular Carcinoma in Liver Transplant Candidates. Clin Gastroenterol Hepatol. 2019 Mar;17(4):748-755.e3. doi: 10.1016/j.cgh.2018.05.057. Epub 2018 Jun 14.</citation>
      <PMID>29908364</PMID>
    </reference>
    <reference>
      <citation>Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.</citation>
      <PMID>28930295</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Zainab Mahmoud Kadry</investigator_full_name>
      <investigator_title>lecturer of medical biochemistry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031532
  org study id: Soh-Med-23-04-25PD
  nct id: NCT06031532
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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) .
  observational model: Case-Control
  time perspective: Prospective
  measure: level Vitamin A and Calcium in serum of Patients With Non-alcoholic Fatty Liver patients
  time frame: 2 months
  description: Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease
  measure: fibroscan ultrasound to Non-alcoholic Fatty Liver patients
  time frame: 2 months
  description: fibroscan measures to Non-alcoholic Fatty Liver patients
  arm group label: cases group
  description: Non-alcoholic fatty liver patients
  arm group label: control group
  description: healthy persons
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  citation: Muthiah MD, Sanyal AJ. Burden of Disease due to Nonalcoholic Fatty Liver Disease. Gastroenterol Clin North Am. 2020 Mar;49(1):1-23. doi: 10.1016/j.gtc.2019.09.007.
  PMID: 32033757
  citation: Raza S, Rajak S, Anjum B, Sinha RA. Molecular links between non-alcoholic fatty liver disease and hepatocellular carcinoma. Hepatoma Res. 2019 Dec 11;5:42. doi: 10.20517/2394-5079.2019.014.
  PMID: 31867441
  citation: Younossi Z, Stepanova M, Ong JP, Jacobson IM, Bugianesi E, Duseja A, Eguchi Y, Wong VW, Negro F, Yilmaz Y, Romero-Gomez M, George J, Ahmed A, Wong R, Younossi I, Ziayee M, Afendy A; Global Nonalcoholic Steatohepatitis Council. Nonalcoholic Steatohepatitis Is the Fastest Growing Cause of Hepatocellular Carcinoma in Liver Transplant Candidates. Clin Gastroenterol Hepatol. 2019 Mar;17(4):748-755.e3. doi: 10.1016/j.cgh.2018.05.057. Epub 2018 Jun 14.
  PMID: 29908364
  citation: Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.
  PMID: 28930295
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Zainab Mahmoud Kadry
  investigator title: lecturer of medical biochemistry
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  sharing ipd: Undecided