HISH: HIV, Immune Activation and Salt Sensitive Hypertension

Sponsor

Mulungushi University (Other)

Overall Status

Completed

CT.gov ID

NCT04459741

Collaborator

University of Zambia (Other), Vanderbilt University Medical Center (Other)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection Hypertension,Essential	Dietary Supplement: Dietary salt (Sodium chloride)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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 weekParticipants 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)

Primary Purpose:

Diagnostic

Official Title:

Hypertension, Dietary Salt and Inflammation

Actual Study Start Date :

Jan 2, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Blood pressure [2 weeks: At the end of the low- and high-salt phases]
Elevated blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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