Skip to main content
OpenTrials
Completed

NCT Number: NCT04459741

HIV, Immune Activation and Salt Sensitive Hypertension

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1-infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Essential Hypertension Genital Diseases HIV Infections Hypertension Hypertension,Essential Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Livingstone Central Hospital

Livingstone, Southern Province, 10101, Zambia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary salt (Sodium chloride)

Dietary Supplement

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.

Primary outcomes

  1. Pro-inflammatory cytokines

    Time frame: 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 outcomes

  1. Blood pressure

    Time frame: 2 weeks: At the end of the low- and high-salt phases

    Elevated blood pressure

Sponsors and collaborators

Lead sponsor

Mulungushi University

Other

Collaborators

  • University of Zambia
  • Vanderbilt University Medical Center

Registry information

Official study title

Hypertension, Dietary Salt and Inflammation

Acronym: HISH

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.