HIV, Immune Activation and Salt Sensitive Hypertension (HISH)

Mulungushi University

Status: Completed

Conditions: Hypertension,Essential; HIV-1-infection

Treatments: Dietary Supplement: Dietary salt (Sodium chloride)

Study type: Interventional

Funder types: Other

Identifiers

NCT04459741

SKM001

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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85 participants in 4 patient groups

HIV+ Hypertensive

Experimental group

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

Treatment:

Dietary Supplement: Dietary salt (Sodium chloride)

HIV+ Normotensive

Other group

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

Treatment:

Dietary Supplement: Dietary salt (Sodium chloride)

HIV- Hypertensive

Experimental group

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

Treatment:

Dietary Supplement: Dietary salt (Sodium chloride)

HIV- Normotensive

Other group

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

Treatment:

Dietary Supplement: Dietary salt (Sodium chloride)