HIV, Immune Activation and Salt Sensitive Hypertension (HISH)

Hypertension, Dietary Salt and Inflammation

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection; Hypertension,Essential
• Intervention / Treatment: Dietary supplement: Dietary salt (Sodium chloride)

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Southern
    • Livingstone, Southern, Zambia, 10101
      • Livingstone Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HIV+ Hypertensive; 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	Dietary supplement: Dietary salt (Sodium chloride); 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.
OTHER: HIV+ Normotensive; 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	Dietary supplement: Dietary salt (Sodium chloride); 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.
EXPERIMENTAL: HIV- Hypertensive; 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	Dietary supplement: Dietary salt (Sodium chloride); 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.
OTHER: HIV- Normotensive; 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	Dietary supplement: Dietary salt (Sodium chloride); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory cytokines	Elevated levels of pro-inflammatory cytokines when compared between low and high salt phase	2 weeks: At the end of the low- and high-salt phases

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Elevated blood pressure	2 weeks: At the end of the low- and high-salt phases

Collaborators and Investigators

• Sponsor: Mulungushi University
• Collaborators: Vanderbilt University Medical Center; University of Zambia
• Investigators: Principal Investigator: Sepiso K Masenga, PhD, Mulungushi University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; Hypertension; Interleukin 6; Salt; Human immunodeficiency virus (HIV); Interleukin 17A
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: SKM001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No