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RecruitingNCT06226636IPROSUpdated Jan 26, 2024

Immediate Pressor Response to Oral Salt

An interventional study of salt in High Blood Pressure, sponsored by Mulungushi University. Recruiting at 2 sites in Zambia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-26.

Sponsored by Mulungushi University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Jul 2023, registered Jan 2024).
  • Started Jul 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The goal of this study is to establish a diagnostic accuracy of an immediate pressor response to oral salt (IPROS) to identify salt sensitivity of blood pressure (SSBP)

Read the detailed description

Participants are given dietary salt and their BP is measured every 10 minutes for 2 hours. IPROS is diagnosed with significant mean arterial pressure increase

For SSBP, participants are put on high salt diet for a week and monitored and low salt week. The Mean arterial pressure difference between high salt and low salt is used to diagnose SSBP

02

Conditions studied

  • High Blood Pressure

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Mulungushi University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants will be included if they are males or females, aged 18-65 years.

Exclusion criteria

Exclusion Criteria:

  • Kidney disease, Cardiovascular disease
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    intervention

    intervention given

    Other: salt

Interventions

  • Othersalt

    After ≥8 hr overnight fasting, participants will be required to ingest 780 mg of sodium (2 g salt) and BP measured every 10 minutes for 2 hours to determine IPROS. For SSBP, Participants are put on low salt (50 mmol Na/day) followed by seven days of high salt diet (250 mmol Na/day). Participants' mean arterial pressure (MAP) difference between low- and high-salt diet will be used to define salt sensitivity (MAP≥8 mmHg) and salt resistance (MAP≤5 mmHg).

06

What researchers measure

Primary outcomes

  1. SSBP

    Salt sensitivity status

    Time frame: 2 weeks

Secondary outcomes

  1. IPROS

    Immediate pressor response

    Time frame: 2 hours

07

Study locations

1 of 2 sites recruiting
  • Livingstone University Teaching Hospital
    Livingstone, Southern 10101, Zambia
    Not yet recruiting
    • Kaseya Chiyenu, MD · Contact
    • Sepiso K Masenga, PhD · Principal investigator
  • Kanyama General Hospital
    Lusaka, 10101, Zambia
    Recruiting
    • Chileleko Siakabanze, MSc · Contact
    • Chileleko Siakabanze, MSc · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — Data set and manuscripts published

Supporting information: Clinical study report

Time frame: 2025

Access criteria: email

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06226636
Lead sponsor
Mulungushi University
Responsible party
Sepiso K. Masenga (Senior Lecturer, Mulungushi University) — Principal investigator
First posted
Jan 26, 2024
Start date
Jul 7, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 26, 2024

Study contacts

Sepiso K Masenga, PhD
Contact
sepisomasenga@gmail.com
+260977674774

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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