HIV, Immune Activation and Salt Sensitive Hypertension

NCT04459741 | Completed

• 1 other identifier: SKM001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection; Hypertension,Essential

Keywords

Inflammation; Human immunodeficiency virus (HIV); Salt; Interleukin 6; Interleukin 17A; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood pressure

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

Study Arms (4)

HIV+ Hypertensive

EXPERIMENTAL

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)

HIV+ Normotensive

OTHER

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)

HIV- Hypertensive

EXPERIMENTAL

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)

HIV- Normotensive

OTHER

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)

Interventions

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.

HIV+ Hypertensive; HIV+ Normotensive; HIV- Hypertensive; HIV- Normotensive

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mulungushi University: lead
• University of Zambia: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Livingstone Central Hospital

Livingstone, Southern Province, 10101, Zambia

Location

Related 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.

  PMID: 31311574 BACKGROUND

MeSH Terms

Conditions

Essential Hypertension; Inflammation; Acquired Immunodeficiency Syndrome; Hypertension

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sepiso K Masenga, PhD

  Mulungushi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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 week

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: January 2, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)