<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/NCT03021889</url>
  </required_header>
  <id_info>
    <org_study_id>150018</org_study_id>
    <nct_id>NCT03021889</nct_id>
  </id_info>
  <brief_title>Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment</brief_title>
  <official_title>Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Universitario La Salle</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and bodily&#xD;
      changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia latter&#xD;
      being associated with a higher chance of cardiovascular events and death.&#xD;
&#xD;
      Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living&#xD;
      with HIV / AIDS in antiretroviral therapy.&#xD;
&#xD;
      Method: This is a randomized clinical trial with young people 13-19 years in outpatient&#xD;
      treatment in a general hospital to present dyslipidemia. The intervention group received&#xD;
      nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control&#xD;
      group received standard care consisting of medical care. Demographic, clinical, nutritional&#xD;
      variables, food surveys and lipid profiles were collected at baseline and at the end of the&#xD;
      study for both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a open randomized clinical trial. The participants were adolescents (13 to 19 years&#xD;
      old) diagnosed with HIV / AIDS from the Pediatric Infectious Disease Outpatient Clinic - zone&#xD;
      4, from a tertiary care university hospital in the South Region in Brazil, along with their&#xD;
      caregivers. Present Dyslipidemia, characterized by Total Cholesterol&gt; 200mg / dL associated&#xD;
      with:Triglycerides ≥ 150mg HDL cholesterol (male &lt;40 mg / dL and female &lt;50 mg / dL) LDL&#xD;
      cholesterol ≥ 160 mg / dL. The clinical profile, immunological, virological, the biochemical&#xD;
      parameters will be accessed by the patient's chart and the dietary parameters will be&#xD;
      evaluated by means of 24-hour reminder instrument. The sample was calculated, using a&#xD;
      software, from an alpha error of 5%, reliability power of 80%, to obtain detection difference&#xD;
      and standard deviation for each of the group of 40, totaling 36 patients.&#xD;
&#xD;
      The randomization will be performed through simple randomization in blocks of 2 patients&#xD;
      generated by computer program, available at www.randomization.com.&#xD;
&#xD;
      The intervention group received nutritional counseling for 12 weeks and weekly flights to&#xD;
      nutritional counseling. The control group received standard care consisting of medical care.&#xD;
      Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected&#xD;
      at baseline and at the end of the study for both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood plasma level of total cholesterol</measure>
    <time_frame>12 months</time_frame>
    <description>Total blood cholesterol level will be assessed by blood test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Food intake</measure>
    <time_frame>12 months</time_frame>
    <description>Food intake will be assessed a 24-hour reminder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>12 months</time_frame>
    <description>Will be assessed by body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood plasma level of triglycerides</measure>
    <time_frame>12 months</time_frame>
    <description>Triglycerides level will be assessed by blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood plasma level of HDL cholesterol</measure>
    <time_frame>12 months</time_frame>
    <description>HDL cholesterol level will be assessed by blood test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Adolescent Behavior</condition>
  <condition>Hiv</condition>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Nutritional therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group received conventional care consisting of usual medical care. The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional therapy</intervention_name>
    <description>The nutritional therapy intervention group received monthly nutritional guidelines for 12 weeks focusing on the diet for dyslipidemia, based on the recommendation of the type I diet of the Clinical Protocol and Therapeutic Guidelines for Management of HIV Infection in children and adolescents. In addition, participants in the intervention group received weekly phone calls for nutritional counseling.</description>
    <arm_group_label>Nutritional therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed HIV infection with a positive result obtained by performing a screening test&#xD;
             for anti-HIV-1 and anti-HIV-2 and at least one confirmatory test;&#xD;
&#xD;
          -  Being on antiretroviral therapy for at least three months prior to the start of the&#xD;
             study;&#xD;
&#xD;
          -  Present current biochemical exams: Dyslipidemia, characterized by Total Cholesterol&gt;&#xD;
             170mg / dL associated with: Triglycerides greater than or equal to LDL cholesterol ≥&#xD;
             130 mg / dL;&#xD;
&#xD;
          -  Availability to participate in the nutritional intervention with a low fat diet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women;&#xD;
&#xD;
          -  Patients with active opportunistic infections;&#xD;
&#xD;
          -  Cognitive deficits;&#xD;
&#xD;
          -  Diabetes mellitus;&#xD;
&#xD;
          -  Patients taking lipid-lowering drugs;&#xD;
&#xD;
          -  Patients who are unaware of their HIV diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelli S de Assis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nurse Research</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV / AIDS</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Nutritional Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03021889
org study id: 150018
nct id: NCT03021889
lead sponsor: 
collaborator: 
has dmc: No
Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and bodily
      changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia latter
      being associated with a higher chance of cardiovascular events and death.

      Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living
      with HIV / AIDS in antiretroviral therapy.

      Method: This is a randomized clinical trial with young people 13-19 years in outpatient
      treatment in a general hospital to present dyslipidemia. The intervention group received
      nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control
      group received standard care consisting of medical care. Demographic, clinical, nutritional
      variables, food surveys and lipid profiles were collected at baseline and at the end of the
      study for both groups.
This is a open randomized clinical trial. The participants were adolescents (13 to 19 years
      old) diagnosed with HIV / AIDS from the Pediatric Infectious Disease Outpatient Clinic - zone
      4, from a tertiary care university hospital in the South Region in Brazil, along with their
      caregivers. Present Dyslipidemia, characterized by Total Cholesterol> 200mg / dL associated
      with:Triglycerides ≥ 150mg HDL cholesterol (male <40 mg / dL and female <50 mg / dL) LDL
      cholesterol ≥ 160 mg / dL. The clinical profile, immunological, virological, the biochemical
      parameters will be accessed by the patient's chart and the dietary parameters will be
      evaluated by means of 24-hour reminder instrument. The sample was calculated, using a
      software, from an alpha error of 5%, reliability power of 80%, to obtain detection difference
      and standard deviation for each of the group of 40, totaling 36 patients.

      The randomization will be performed through simple randomization in blocks of 2 patients
      generated by computer program, available at www.randomization.com.

      The intervention group received nutritional counseling for 12 weeks and weekly flights to
      nutritional counseling. The control group received standard care consisting of medical care.
      Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected
      at baseline and at the end of the study for both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: Blood plasma level of total cholesterol
time frame: 12 months
description: Total blood cholesterol level will be assessed by blood test
measure: Food intake
time frame: 12 months
description: Food intake will be assessed a 24-hour reminder
measure: Nutritional status
time frame: 12 months
description: Will be assessed by body mass index
measure: Blood plasma level of triglycerides
time frame: 12 months
description: Triglycerides level will be assessed by blood test
measure: Blood plasma level of HDL cholesterol
time frame: 12 months
description: HDL cholesterol level will be assessed by blood test
arm group label: Nutritional therapy group
arm group type: Experimental
description: The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.
arm group label: Control group
arm group type: Other
description: The control group received conventional care consisting of usual medical care. The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.
intervention type: Behavioral
intervention name: Nutritional therapy
description: The nutritional therapy intervention group received monthly nutritional guidelines for 12 weeks focusing on the diet for dyslipidemia, based on the recommendation of the type I diet of the Clinical Protocol and Therapeutic Guidelines for Management of HIV Infection in children and adolescents. In addition, participants in the intervention group received weekly phone calls for nutritional counseling.
arm group label: Nutritional therapy group
intervention type: Behavioral
intervention name: Control group
description: The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.
arm group label: Control group
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: No
last name: Michelli S de Assis, PhD
role: Principal Investigator
affiliation: Nurse Research
responsible party type: Sponsor
mesh term: Dyslipidemias
sharing ipd: Undecided