HIV-1-infectionHISHNCT04459741
HIV, Immune Activation and Salt Sensitive Hypertension
A study testing Dietary salt (Sodium chloride) in people with HIV-1-infection and Hypertension,Essential, run by Mulungushi University at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Hypertension,Essential
- What is being tested?
- Dietary salt (Sodium chloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteZambia
- Study dates
- 2 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Livingstone Central Hospital
Livingstone, Southern Province, 10101
About this study
Official title: Hypertension, Dietary Salt and Inflammation
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
- Being tested
- Dietary salt (Sodium chloride)
- Keywords
- Inflammation, Human immunodeficiency virus (HIV), Salt, Interleukin 6, Interleukin 17A, Hypertension
- Medical subject headings
- Essential Hypertension, Inflammation, Acquired Immunodeficiency Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Dietary salt (Sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-inflammatory cytokines
Elevated levels of pro-inflammatory cytokines when compared between low and high salt phase
Measured: 2 weeks: At the end of the low- and high-salt phases
Secondary outcomes (1)
Blood pressure
Elevated blood pressure
Measured: 2 weeks: At the end of the low- and high-salt phases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start2 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 week
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mulungushi University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zambia, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Sepiso K. Masenga, Mulungushi University
- Investigators
- Sepiso K Masenga, PhD, Principal investigator, Mulungushi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459741
- Sponsor's protocol ID
- SKM001
- Acronym
- HISH
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31311574
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension, Dietary Salt and Inflammation
- ClinicalTrials.gov ID
- NCT04459741
- Acronym / sponsor ID
- HISH / SKM001
- Conditions
- HIV-1-infection, Hypertension,Essential
- Keywords
- Inflammation, Human immunodeficiency virus (HIV), Salt, Interleukin 6, Interleukin 17A, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Mulungushi UniversityUniversity, hospital or other
- Collaborators
- University of Zambia, Vanderbilt University Medical Center
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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 week
| Arm | Type | Receives |
|---|---|---|
| HIV+ Hypertensive | Experimental | Dietary Supplement: Dietary salt (Sodium chloride)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 |
| HIV+ Normotensive | Other | Dietary Supplement: Dietary salt (Sodium chloride)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 |
| HIV- Hypertensive | Experimental | Dietary Supplement: Dietary salt (Sodium chloride)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 |
| HIV- Normotensive | Other | Dietary Supplement: Dietary salt (Sodium chloride)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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | HIV+ Hypertensive, HIV+ Normotensive, HIV- Hypertensive, HIV- Normotensive |
Primary outcome
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
1 secondary outcome
Blood pressure
Time frame: 2 weeks: At the end of the low- and high-salt phases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 31311574Masenga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sepiso K Masenga, PhD principal investigator
Mulungushi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary salt (Sodium chloride) in people with HIV-1-infection and Hypertension,Essential, run by Mulungushi University at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pro-inflammatory cytokines (time frame: 2 weeks: At the end of the low- and high-salt phases). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04459741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.