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HIV, Immune Activation and Salt Sensitive Hypertension

Hypertension, Dietary Salt and Inflammation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04459741
Acronym
HISH
Enrollment
85
Registered
2020-07-07
Start date
2019-01-02
Completion date
2019-12-31
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection, Hypertension,Essential

Keywords

Inflammation, Human immunodeficiency virus (HIV), Salt, Interleukin 6, Interleukin 17A, Hypertension

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.

Interventions

DIETARY_SUPPLEMENTDietary 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.

Sponsors

University of Zambia
CollaboratorOTHER
Vanderbilt University Medical Center
CollaboratorOTHER
Mulungushi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pro-inflammatory cytokines2 weeks: At the end of the low- and high-salt phasesElevated levels of pro-inflammatory cytokines when compared between low and high salt phase

Secondary

MeasureTime frameDescription
Blood pressure2 weeks: At the end of the low- and high-salt phasesElevated blood pressure

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026