<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/NCT04459741</url>
  </required_header>
  <id_info>
    <org_study_id>SKM001</org_study_id>
    <nct_id>NCT04459741</nct_id>
  </id_info>
  <brief_title>HIV, Immune Activation and Salt Sensitive Hypertension</brief_title>
  <acronym>HISH</acronym>
  <official_title>Hypertension, Dietary Salt and Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mulungushi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zambia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mulungushi 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>
      High dietary salt is associated with immune activation, elevated levels of inflammatory&#xD;
      cytokines and hypertension in murine models. Hypertension is independently associated with&#xD;
      inflammation in both murine studies and studies in humans. In people living with HIV, these&#xD;
      interactions are not well established. The aim of this study is to determine the effect of&#xD;
      excess dietary salt on immune cell activation, pro- and anti-inflammatory cytokines and blood&#xD;
      pressure between individuals with and without hypertension among people living with HIV and&#xD;
      HIV negative persons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Participants are instructed on salt deprivation for a week followed by a low salt (4 grams) diet for one week and switched to high salt (9 grams) for the following one week</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pro-inflammatory cytokines</measure>
    <time_frame>2 weeks: At the end of the low- and high-salt phases</time_frame>
    <description>Elevated levels of pro-inflammatory cytokines when compared between low and high salt phase</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>2 weeks: At the end of the low- and high-salt phases</time_frame>
    <description>Elevated blood pressure</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>HIV-1-infection</condition>
  <condition>Hypertension,Essential</condition>
  <arm_group>
    <arm_group_label>HIV+ Hypertensive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV+ Normotensive</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV- Hypertensive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV- Normotensive</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary salt (Sodium chloride)</intervention_name>
    <description>Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.</description>
    <arm_group_label>HIV+ Hypertensive</arm_group_label>
    <arm_group_label>HIV+ Normotensive</arm_group_label>
    <arm_group_label>HIV- Hypertensive</arm_group_label>
    <arm_group_label>HIV- Normotensive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (aged 18 and above) who will be required to verbally consent and sign a consent&#xD;
             form&#xD;
&#xD;
          -  HIV positive or HIV Normotensive individuals or hypertensive If HIV, on antiretroviral&#xD;
             therapy ART treated hypertensive individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existence of comorbidities such as diabetes mellitus and cancer Existing and recent&#xD;
             past opportunistic infections, syphilis, hepatitis C and B virus infection and&#xD;
             tuberculosis infection;&#xD;
&#xD;
          -  Sick persons (clients seeking healthcare due to an illness rather than routine ART&#xD;
             clinic reviews)&#xD;
&#xD;
          -  Those with recent and current alcohol consumption and smoking status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sepiso K Masenga, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mulungushi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Livingstone Central Hospital</name>
      <address>
        <city>Livingstone</city>
        <state>Southern</state>
        <zip>10101</zip>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <reference>
    <citation>Masenga SK, Hamooya BM, Nzala S, Kwenda G, Heimburger DC, Mutale W, Koethe JR, Kirabo A, Munsaka SM. HIV, immune activation and salt-sensitive hypertension (HISH): a research proposal. BMC Res Notes. 2019 Jul 16;12(1):424. doi: 10.1186/s13104-019-4470-2.</citation>
    <PMID>31311574</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mulungushi University</investigator_affiliation>
    <investigator_full_name>Sepiso K. Masenga</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Inflammation</keyword>
  <keyword>Human immunodeficiency virus (HIV)</keyword>
  <keyword>Salt</keyword>
  <keyword>Interleukin 6</keyword>
  <keyword>Interleukin 17A</keyword>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04459741
org study id: SKM001
nct id: NCT04459741
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
High dietary salt is associated with immune activation, elevated levels of inflammatory
      cytokines and hypertension in murine models. Hypertension is independently associated with
      inflammation in both murine studies and studies in humans. In people living with HIV, these
      interactions are not well established. The aim of this study is to determine the effect of
      excess dietary salt on immune cell activation, pro- and anti-inflammatory cytokines and blood
      pressure between individuals with and without hypertension among people living with HIV and
      HIV negative persons.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants are instructed on salt deprivation for a week followed by a low salt (4 grams) diet for one week and switched to high salt (9 grams) for the following one week
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pro-inflammatory cytokines
time frame: 2 weeks: At the end of the low- and high-salt phases
description: Elevated levels of pro-inflammatory cytokines when compared between low and high salt phase
measure: Blood pressure
time frame: 2 weeks: At the end of the low- and high-salt phases
description: Elevated blood pressure
arm group label: HIV+ Hypertensive
arm group type: Experimental
description: Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days
arm group label: HIV+ Normotensive
arm group type: Other
description: Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days
arm group label: HIV- Hypertensive
arm group type: Experimental
description: Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days
arm group label: HIV- Normotensive
arm group type: Other
description: Participants receive 4 grams of dietary salt (equivalent of 1, 560 mg sodium) everyday for seven days followed by 9 grams (equivalent of 3, 510 mg sodium) of dietary salt for the following seven days
intervention type: Dietary Supplement
intervention name: Dietary salt (Sodium chloride)
description: Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.
arm group label: HIV+ Hypertensive
arm group label: HIV+ Normotensive
arm group label: HIV- Hypertensive
arm group label: HIV- Normotensive
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sepiso K Masenga, PhD
role: Principal Investigator
affiliation: Mulungushi University
facility: 
country: Zambia
citation: Masenga SK, Hamooya BM, Nzala S, Kwenda G, Heimburger DC, Mutale W, Koethe JR, Kirabo A, Munsaka SM. HIV, immune activation and salt-sensitive hypertension (HISH): a research proposal. BMC Res Notes. 2019 Jul 16;12(1):424. doi: 10.1186/s13104-019-4470-2.
PMID: 31311574
responsible party type: Principal Investigator
investigator affiliation: Mulungushi University
investigator full name: Sepiso K. Masenga
investigator title: Dr
mesh term: Hypertension
mesh term: Essential Hypertension
sharing ipd: No