HIV, Immune Activation and Salt Sensitive Hypertension

NCT ID: NCT04459741

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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HIV-1-infection Hypertension,Essential

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dietary salt (Sodium chloride)

Intervention Type 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+ 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

Group Type OTHER

Dietary salt (Sodium chloride)

Intervention Type 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

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

Group Type EXPERIMENTAL

Dietary salt (Sodium chloride)

Intervention Type 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- 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

Group Type OTHER

Dietary salt (Sodium chloride)

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zambia

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Mulungushi University

OTHER

Sponsor Role lead

Responsible Party

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Sepiso K. Masenga

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sepiso K Masenga, PhD

Role: PRINCIPAL_INVESTIGATOR

Mulungushi University

Locations

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Livingstone Central Hospital

Livingstone, Southern Province, Zambia

Site Status

Countries

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Zambia

References

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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.

Reference Type BACKGROUND
PMID: 31311574 (View on PubMed)

Other Identifiers

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SKM001

Identifier Type: -

Identifier Source: org_study_id

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