Blood PressureAcuteSSNCT04844255
Acute Salt Sensitivity of Blood Pressure
A study testing dietary salt in people with Blood Pressure, run by Mulungushi University at 1 site in Zambia.
Trial summary
Dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ASS) while not affecting others. It is hypothesized that ASS is a risk factor for hypertension. However, no thresholds or diagnostic guideline is available for ASS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- dietary salt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteZambia
- Study dates
- 1 Dec 2020to 28 Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and above. Normotensive. If Hypertensive (should be off antihypertensive medication at least 2 weeks prior to the study)
Who cannot join
- diabetes patients, ill participants
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Livingstone Central Hospital
Livingstone, Southern Province, 10101
About this study
Official title: HIV Integrated Personalized Care Approach to the Prevention, Diagnosis, and Control of Salt-sensitive Hypertension: The HIPO CAP DICTSH STUDY
Dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ASS) while not affecting others. It is hypothesized that ASS is a risk factor for hypertension. However, no thresholds or diagnostic guideline is available for ASS. This study is the first aim in the main study (HIPO CAP DITSH Study) aimed at determining the threshold or blood pressure cut-offs for ASS upon ingesting dietary salt.
- Conditions
- Blood Pressure
- Being tested
- dietary salt
- Keywords
- salt sensitivity, salt, acute salt sensitivity, Blood pressure, Mean arterial pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary saltDietary supplement
2 grams of dietary salt
| Study group | Role | What they receive |
|---|---|---|
| Pre and post intervention group | Other | Same individuals are examined before and after taking 2 tablets of salt Receives: Dietary Supplement: dietary salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute salt sensitivity
Mean arterial pressure change of 10 mmHg
Measured: 160 minutes
Secondary outcomes (2)
Diastolic blood pressure change
Diastolic blood pressure change of equal to or more than 10 mmHg
Measured: 160 minutes
Systolic blood pressure change
Systolic blood pressure change of equal to or more than 20 mmHg
Measured: 160 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Dec 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
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 Blood PressureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Time series design
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mulungushi University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zambia
- 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
- NCT04844255
- Sponsor's protocol ID
- PACTR202102852000433
- Acronym
- AcuteSS
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available after publication upon request.
Publications
Masenga SK, Hamooya BM, Patel KP, Kirabo A. Erythrocyte glycocalyx sensitivity to sodium is associated with salt sensitivity of blood pressure in women but not men. Front Nutr. 2024 Mar 8;11:1334853. doi: 10.3389/fnut.2024.1334853. eCollection 2024.
PubMed 38524849
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Integrated Personalized Care Approach to the Prevention, Diagnosis, and Control of Salt-sensitive Hypertension: The HIPO CAP DICTSH STUDY
- ClinicalTrials.gov ID
- NCT04844255
- Acronym / sponsor ID
- AcuteSS / PACTR202102852000433
- Conditions
- Blood Pressure
- Keywords
- salt sensitivity, salt, acute salt sensitivity, Blood pressure, Mean arterial pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Mulungushi UniversityUniversity, hospital or other
- Collaborators
- University of Zambia
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 14 Apr 2021 (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.
Dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ASS) while not affecting others. It is hypothesized that ASS is a risk factor for hypertension. However, no thresholds or diagnostic guideline is available for ASS. This study is the first aim in the main study (HIPO CAP DITSH Study) aimed at determining the threshold or blood pressure cut-offs for ASS upon ingesting dietary salt.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Time series design
| Arm | Type | Receives |
|---|---|---|
| Pre and post intervention group | Other | Dietary Supplement: dietary saltSame individuals are examined before and after taking 2 tablets of salt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years and above. Normotensive. If Hypertensive (should be off antihypertensive medication at least 2 weeks prior to the study)
Key exclusion criteria (1 listed)
- diabetes patients, ill participants
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 salt2 grams of dietary salt | Dietary supplement | Pre and post intervention group |
Primary outcome
Acute salt sensitivity
Time frame: 160 minutes
Mean arterial pressure change of 10 mmHg
2 secondary outcomes
Diastolic blood pressure change
Time frame: 160 minutes
Systolic blood pressure change
Time frame: 160 minutes
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 15 Apr 2021.
- Derived from this study: PubMed 38524849Masenga SK, Hamooya BM, Patel KP, Kirabo A. Erythrocyte glycocalyx sensitivity to sodium is associated with salt sensitivity of blood pressure in women but not men. Front Nutr. 2024 Mar 8;11:1334853. doi: 10.3389/fnut.2024.1334853. eCollection 2024.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available after publication upon request.
Related trials for Blood Pressure
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Recruiting
IMST for Dementia Risk Reduction
Systolic Blood Pressure, Blood Pressure
RecruitingPhase 2
Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans
Salt Sensitivity of Blood Pressure, High Blood Pressure
Not yet recruiting
Team-Based Shared Decision-Making Program in Hypertension Control (Healthy Heart - BP Program)
Hypertension (HTN), Blood Pressure
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
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 in people with Blood Pressure, 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 1 inclusion and 1 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 15 Apr 2021. 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?
Acute salt sensitivity (time frame: 160 minutes). 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 NCT04844255, 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 15 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.