Acute Salt Sensitivity of Blood Pressure (AcuteSS)

April 13, 2021 updated by: Sepiso K. Masenga, Mulungushi University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
    • Southern
      • Livingstone, Southern, Zambia, 10101
        • Livingstone Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 years and above. Normotensive. If Hypertensive (should be off antihypertensive medication at least 2 weeks prior to the study)

Exclusion Criteria:

  • diabetes patients, ill participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Pre and post intervention group
Same individuals are examined before and after taking 2 tablets of salt
Dietary supplement: dietary salt
2 grams of dietary salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute salt sensitivity
Time Frame: 160 minutes
Mean arterial pressure change of 10 mmHg
160 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic blood pressure change
Time Frame: 160 minutes
Diastolic blood pressure change of equal to or more than 10 mmHg
160 minutes
Systolic blood pressure change
Time Frame: 160 minutes
Systolic blood pressure change of equal to or more than 20 mmHg
160 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mulungushi University

Collaborators

University of Zambia

Investigators

  • Principal Investigator: Sepiso K Masenga, PhD, Mulungushi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ACTUAL)

February 28, 2021

Study Completion (ACTUAL)

February 28, 2021

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (ACTUAL)

April 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PACTR202102852000433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be made available after publication upon request.

IPD Sharing Time Frame

After publishing results

IPD Sharing Access Criteria

email and published article (open access)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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