HIV, Immune Activation and Salt Sensitive Hypertension

Not Applicable

Completed

• Conditions: Hypertension,Essential; HIV-1-infection
• Interventions: Dietary Supplement: Dietary salt (Sodium chloride)

• Registration Number: NCT04459741
• Lead Sponsor: Mulungushi University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HIV- Normotensive	Dietary salt (Sodium chloride)	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
HIV+ Hypertensive	Dietary salt (Sodium chloride)	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
HIV+ Normotensive	Dietary salt (Sodium chloride)	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
HIV- Hypertensive	Dietary salt (Sodium chloride)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood pressure	2 weeks: At the end of the low- and high-salt phases	Elevated blood pressure

Trial Locations

Locations (1)

Livingstone Central Hospital; 🇿🇲 Livingstone, Southern, Zambia