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/NCT06009744</url>
    </required_header>
    <id_info>
      <org_study_id>HJM 005/32-I</org_study_id>
      <nct_id>NCT06009744</nct_id>
    </id_info>
    <brief_title>Vitamin C and Zinc in Patients With Enterocutaneous Fistulas.</brief_title>
    <acronym>VITAC</acronym>
    <official_title>Effectiveness of Doses of Vitamin c and Zinc in Patients With High Enterocutaneous Fistulas Receiving Nutrition Parenteral Therapy on Closure and Recurrence. Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Juarez de Mexico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Juarez de Mexico</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Various micronutrients play an important role in the process of closure and recurrence of&#xD;
        enterocutaneous fistulas, such as Vitamin C and Zinc. However, there is no specific&#xD;
        recommendation on the dose of these nutrients by parenteral route.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized, control trial to investigate the effect and safety of doses of vitamin&#xD;
        c and zinc in patients with high enterocutaneous fistulas receiving who need nutrition&#xD;
        parenteral therapy on closure and recurrence.&#xD;
  &#xD;
        Screening will be made to select eligible participants before intervention. Participants were&#xD;
        randomly assigned to one of two groups: group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids&#xD;
        and C 100-300 mg/d y zinc 3-5 mg/d; group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and&#xD;
        Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d.&#xD;
  &#xD;
        Demographic variables and subjective global assessment scale will be recorded and applied.&#xD;
        Anthropometric measurements (weight and body mass index) will be evaluated upon admission and&#xD;
        weekly until hospital discharge.&#xD;
  &#xD;
        Biochemical markers (albumin, lymphocytes, prealbumin, transferrin, cholesterol, creatinine)&#xD;
        and serum metabolic profile (glucose, liver function test) will be measured weekly. During&#xD;
        hospitalization, patients will be evaluated daily until the closure of the fistula and/or&#xD;
        follow-up at 30 days, monitoring capillary blood glucose, insulin expenditure, and fistula&#xD;
        volume.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and C 100-300 mg/d y zinc 3-5 mg/d Group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fistula closure</measure>
      <time_frame>follow-up at 30 days</time_frame>
      <description>Evaluate enterocutaneous fistula closure rate.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recurrence of fistula</measure>
      <time_frame>follow-up at 30 days</time_frame>
      <description>Evaluate the recurrence of enterocutaneous fistula</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Medical-nutritional status</measure>
      <time_frame>24-72 hours after hospital admission</time_frame>
      <description>Medical-nutritional status: subjective global assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical-nutritional status</measure>
      <time_frame>24-72 hours after hospital admission</time_frame>
      <description>Medical-nutritional status: nutritional risk index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>biochemical markers</measure>
      <time_frame>every week until a maximum follow-up at 30 days</time_frame>
      <description>Changes in nutritional status biochemical markers: albumin in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>biochemical markers</measure>
      <time_frame>every week until a maximum follow-up at 30 days</time_frame>
      <description>Changes in nutritional status biochemical markers: lymphocytes in serum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>biochemical markers</measure>
      <time_frame>every week until a maximum follow-up at 30 days</time_frame>
      <description>Changes in nutritional status biochemical markers: prealbumin in serum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>biochemical markers</measure>
      <time_frame>every week until a maximum follow-up at 30 days</time_frame>
      <description>Changes in nutritional status biochemical markers: transferrin in serum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metabolic profile</measure>
      <time_frame>every week until a maximum follow-up at 30 days</time_frame>
      <description>Changes in metabolic profile in serum glucose concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metabolic profile</measure>
      <time_frame>every 15 days up to a maximum follow-up at 30 days</time_frame>
      <description>Changes in metabolic profile in serum tests liver</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay of patients</measure>
      <time_frame>follow-up at 30 days</time_frame>
      <description>Determine the length of hospital stay of patients.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Enterocutaneous Fistulas</condition>
    <arm_group>
      <arm_group_label>Vit C y zinc bajo</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vit C and zinc alto</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Low-dose vitamin C and zinc</intervention_name>
      <description>This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 100-300 mg/d and zinc 3-5 mg/d</description>
      <arm_group_label>Vit C y zinc bajo</arm_group_label>
      <other_name>Low Vit C y zinc</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>High-dose vitamin C and zinc</intervention_name>
      <description>This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d</description>
      <arm_group_label>Vit C and zinc alto</arm_group_label>
      <other_name>High Vit C y zinc</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women and men&#xD;
  &#xD;
            -  &gt;18 years and &lt;70 years old.&#xD;
  &#xD;
            -  Diagnosis of high-output enterocutaneous fistula for the first time&#xD;
  &#xD;
            -  Need for parenteral nutrition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Octreotide use&#xD;
  &#xD;
            -  Palliative care&#xD;
  &#xD;
            -  Steroid use&#xD;
  &#xD;
            -  Oxalate nephropathy&#xD;
  &#xD;
            -  G6PD deficiency&#xD;
  &#xD;
            -  Hemochromatosis&#xD;
  &#xD;
            -  Abdominal surgeries in the last 6 months&#xD;
  &#xD;
            -  Hospitalizations for more than 15 days in the last 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elizabeth Pérez Cruz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Juarez de Mexico</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elizabeth Pérez Cruz</last_name>
      <phone>525557477560</phone>
      <phone_ext>7497</phone_ext>
      <email>pece_liz@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Salvador Ortiz Gutiérrez</last_name>
      <phone>525557477560</phone>
      <phone_ext>7497</phone_ext>
      <email>sortizgtz@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Juárez de México</name>
        <address>
          <city>Ciudad de México</city>
          <state>Cdmx</state>
          <zip>07760</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elizabeth PEREZ-CRUZ, MD</last_name>
        <phone>5557477560</phone>
        <phone_ext>7497</phone_ext>
        <email>pece_liz@yahoo.com.mx</email>
      </contact>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <reference>
      <citation>Jeejeebhoy K. Zinc: an essential trace element for parenteral nutrition. Gastroenterology. 2009 Nov;137(5 Suppl):S7-12. doi: 10.1053/j.gastro.2009.08.014.</citation>
      <PMID>19874952</PMID>
    </reference>
    <reference>
      <citation>Yanase F, Fujii T, Naorungroj T, Belletti A, Luethi N, Carr AC, Young PJ, Bellomo R. Harm of IV High-Dose Vitamin C Therapy in Adult Patients: A Scoping Review. Crit Care Med. 2020 Jul;48(7):e620-e628. doi: 10.1097/CCM.0000000000004396.</citation>
      <PMID>32404636</PMID>
    </reference>
    <reference>
      <citation>Couper C, Doriot A, Siddiqui MTR, Steiger E. Nutrition Management of the High-Output Fistulae. Nutr Clin Pract. 2021 Apr;36(2):282-296. doi: 10.1002/ncp.10608. Epub 2020 Dec 24.</citation>
      <PMID>33368576</PMID>
    </reference>
    <reference>
      <citation>Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.</citation>
      <PMID>28385477</PMID>
    </reference>
    <reference>
      <citation>Girard E, Messager M, Sauvanet A, Benoist S, Piessen G, Mabrut JY, Mariette C. Anastomotic leakage after gastrointestinal surgery: diagnosis and management. J Visc Surg. 2014 Dec;151(6):441-50. doi: 10.1016/j.jviscsurg.2014.10.004. Epub 2014 Oct 22.</citation>
      <PMID>25455960</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Juarez de Mexico</investigator_affiliation>
      <investigator_full_name>ELIZABETH PEREZ CRUZ</investigator_full_name>
      <investigator_title>MD, MSc, Prof.</investigator_title>
    </responsible_party>
    <keyword>enterocutaneous fistulas</keyword>
    <keyword>Vitamin C</keyword>
    <keyword>Zinc</keyword>
    <keyword>Parenteral nutrition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Fistula</mesh_term>
      <mesh_term>Fistula</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamins</mesh_term>
      <mesh_term>Ascorbic Acid</mesh_term>
      <mesh_term>Zinc</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06009744
  org study id: HJM 005/32-I
  nct id: NCT06009744
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Various micronutrients play an important role in the process of closure and recurrence of
        enterocutaneous fistulas, such as Vitamin C and Zinc. However, there is no specific
        recommendation on the dose of these nutrients by parenteral route.
  This is a randomized, control trial to investigate the effect and safety of doses of vitamin
        c and zinc in patients with high enterocutaneous fistulas receiving who need nutrition
        parenteral therapy on closure and recurrence.
  
        Screening will be made to select eligible participants before intervention. Participants were
        randomly assigned to one of two groups: group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids
        and C 100-300 mg/d y zinc 3-5 mg/d; group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and
        Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d.
  
        Demographic variables and subjective global assessment scale will be recorded and applied.
        Anthropometric measurements (weight and body mass index) will be evaluated upon admission and
        weekly until hospital discharge.
  
        Biochemical markers (albumin, lymphocytes, prealbumin, transferrin, cholesterol, creatinine)
        and serum metabolic profile (glucose, liver function test) will be measured weekly. During
        hospitalization, patients will be evaluated daily until the closure of the fistula and/or
        follow-up at 30 days, monitoring capillary blood glucose, insulin expenditure, and fistula
        volume.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Group a) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and C 100-300 mg/d y zinc 3-5 mg/d Group b) 25-35 kcal/K/d, 1.3-1.5 g/K/d of amino acids and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Fistula closure
  time frame: follow-up at 30 days
  description: Evaluate enterocutaneous fistula closure rate.
  measure: Recurrence of fistula
  time frame: follow-up at 30 days
  description: Evaluate the recurrence of enterocutaneous fistula
  measure: Medical-nutritional status
  time frame: 24-72 hours after hospital admission
  description: Medical-nutritional status: subjective global assessment
  measure: Medical-nutritional status
  time frame: 24-72 hours after hospital admission
  description: Medical-nutritional status: nutritional risk index
  measure: biochemical markers
  time frame: every week until a maximum follow-up at 30 days
  description: Changes in nutritional status biochemical markers: albumin in serum
  measure: biochemical markers
  time frame: every week until a maximum follow-up at 30 days
  description: Changes in nutritional status biochemical markers: lymphocytes in serum.
  measure: biochemical markers
  time frame: every week until a maximum follow-up at 30 days
  description: Changes in nutritional status biochemical markers: prealbumin in serum.
  measure: biochemical markers
  time frame: every week until a maximum follow-up at 30 days
  description: Changes in nutritional status biochemical markers: transferrin in serum.
  measure: Metabolic profile
  time frame: every week until a maximum follow-up at 30 days
  description: Changes in metabolic profile in serum glucose concentration
  measure: Metabolic profile
  time frame: every 15 days up to a maximum follow-up at 30 days
  description: Changes in metabolic profile in serum tests liver
  measure: Length of hospital stay of patients
  time frame: follow-up at 30 days
  description: Determine the length of hospital stay of patients.
  arm group label: Vit C y zinc bajo
  arm group type: Sham Comparator
  description: Parenteral nutrition + Vitamin C 100-300 mg/d y zinc 3-5 mg/d
  arm group label: Vit C and zinc alto
  arm group type: Active Comparator
  description: Parenteral nutrition + Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d
  intervention type: Drug
  intervention name: Low-dose vitamin C and zinc
  description: This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 100-300 mg/d and zinc 3-5 mg/d
  arm group label: Vit C y zinc bajo
  other name: Low Vit C y zinc
  intervention type: Drug
  intervention name: High-dose vitamin C and zinc
  description: This is a randomized, control trial to investigate the effect of Vitamin C and Zinc in patients with enterocutaneous fistulas receiving nutrition parenteral therapy and Vitamin C 1000-2000 mg/d y zinc 10-15 mg/d
  arm group label: Vit C and zinc alto
  other name: High Vit C y zinc
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Elizabeth Pérez Cruz
  role: Principal Investigator
  affiliation: Hospital Juarez de Mexico
  last name: Elizabeth Pérez Cruz
  phone: 525557477560
  phone ext: 7497
  email: pece_liz@hotmail.com
  last name: Salvador Ortiz Gutiérrez
  phone: 525557477560
  phone ext: 7497
  email: sortizgtz@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Mexico
  citation: Jeejeebhoy K. Zinc: an essential trace element for parenteral nutrition. Gastroenterology. 2009 Nov;137(5 Suppl):S7-12. doi: 10.1053/j.gastro.2009.08.014.
  PMID: 19874952
  citation: Yanase F, Fujii T, Naorungroj T, Belletti A, Luethi N, Carr AC, Young PJ, Bellomo R. Harm of IV High-Dose Vitamin C Therapy in Adult Patients: A Scoping Review. Crit Care Med. 2020 Jul;48(7):e620-e628. doi: 10.1097/CCM.0000000000004396.
  PMID: 32404636
  citation: Couper C, Doriot A, Siddiqui MTR, Steiger E. Nutrition Management of the High-Output Fistulae. Nutr Clin Pract. 2021 Apr;36(2):282-296. doi: 10.1002/ncp.10608. Epub 2020 Dec 24.
  PMID: 33368576
  citation: Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
  PMID: 28385477
  citation: Girard E, Messager M, Sauvanet A, Benoist S, Piessen G, Mabrut JY, Mariette C. Anastomotic leakage after gastrointestinal surgery: diagnosis and management. J Visc Surg. 2014 Dec;151(6):441-50. doi: 10.1016/j.jviscsurg.2014.10.004. Epub 2014 Oct 22.
  PMID: 25455960
  responsible party type: Principal Investigator
  investigator affiliation: Hospital Juarez de Mexico
  investigator full name: ELIZABETH PEREZ CRUZ
  investigator title: MD, MSc, Prof.
  mesh term: Intestinal Fistula
  mesh term: Fistula
  mesh term: Vitamins
  mesh term: Ascorbic Acid
  mesh term: Zinc
  sharing ipd: No