HIV, Immune Activation and Salt Sensitive Hypertension

HIV-1-infection Clinical Trial

— HISH  

Official title:

Hypertension, Dietary Salt and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459741
• Other study ID #: SKM001
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: Mulungushi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• HIV-1-infection
• Hypertension
• Hypertension,Essential

Intervention

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.

Locations

Country	Name	City	State
Zambia	Livingstone Central Hospital	Livingstone	Southern

Sponsors (3)

Lead Sponsor	Collaborator
Mulungushi University	University of Zambia, Vanderbilt University Medical Center

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood pressure	Elevated blood pressure	2 weeks: At the end of the low- and high-salt phases