Back to resultsHIV, Immune Activation and Salt Sensitive Hypertension (HISH)
Primary Purpose
HIV-1-infection, Hypertension,Essential
Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Dietary salt (Sodium chloride)
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV-1-infection focused on measuring Inflammation, Human immunodeficiency virus (HIV), Salt, Interleukin 6, Interleukin 17A, Hypertension
Eligibility Criteria
Inclusion Criteria:
- Adults (aged 18 and above) who will be required to verbally consent and sign a consent form
- HIV positive or HIV Normotensive individuals or hypertensive If HIV, on antiretroviral therapy ART treated hypertensive individuals
Exclusion Criteria:
- Existence of comorbidities such as diabetes mellitus and cancer Existing and recent past opportunistic infections, syphilis, hepatitis C and B virus infection and tuberculosis infection;
- Sick persons (clients seeking healthcare due to an illness rather than routine ART clinic reviews)
- Those with recent and current alcohol consumption and smoking status
Sites / Locations
- Livingstone Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
HIV+ Hypertensive
HIV+ Normotensive
HIV- Hypertensive
HIV- Normotensive
Arm 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
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
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
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
Outcomes
Primary Outcome Measures
Pro-inflammatory cytokines
Elevated levels of pro-inflammatory cytokines when compared between low and high salt phase
Secondary Outcome Measures
Blood pressure
Elevated blood pressure
Full Information
NCT ID
NCT04459741
First Posted
July 1, 2020
Last Updated
July 1, 2020
Sponsor
Mulungushi University
Collaborators
University of Zambia, Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04459741
Brief Title
HIV, Immune Activation and Salt Sensitive Hypertension
Acronym
HISH
Official Title
Hypertension, Dietary Salt and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mulungushi University
Collaborators
University of Zambia, Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection, Hypertension,Essential
Keywords
Inflammation, Human immunodeficiency virus (HIV), Salt, Interleukin 6, Interleukin 17A, Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIV+ Hypertensive
Arm Type
Experimental
Arm 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 Title
HIV+ Normotensive
Arm Type
Other
Arm 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 Title
HIV- Hypertensive
Arm Type
Experimental
Arm 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 Title
HIV- Normotensive
Arm Type
Other
Arm 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(s)
Dietary salt (Sodium chloride)
Intervention 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.
Primary Outcome Measure Information:
Title
Pro-inflammatory cytokines
Description
Elevated levels of pro-inflammatory cytokines when compared between low and high salt phase
Time Frame
2 weeks: At the end of the low- and high-salt phases
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Elevated blood pressure
Time Frame
2 weeks: At the end of the low- and high-salt phases
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults (aged 18 and above) who will be required to verbally consent and sign a consent form
HIV positive or HIV Normotensive individuals or hypertensive If HIV, on antiretroviral therapy ART treated hypertensive individuals
Exclusion Criteria:
Existence of comorbidities such as diabetes mellitus and cancer Existing and recent past opportunistic infections, syphilis, hepatitis C and B virus infection and tuberculosis infection;
Sick persons (clients seeking healthcare due to an illness rather than routine ART clinic reviews)
Those with recent and current alcohol consumption and smoking status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sepiso K Masenga, PhD
Organizational Affiliation
Mulungushi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Livingstone Central Hospital
City
Livingstone
State/Province
Southern
ZIP/Postal Code
10101
Country
Zambia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31311574
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.
Results Reference
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HIV, Immune Activation and Salt Sensitive Hypertension
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