NCT06226636

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2.4 years

First QC Date

January 18, 2024

Last Update Submit

January 18, 2024

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • SSBP

    Salt sensitivity status

    2 weeks

Secondary Outcomes (1)

  • IPROS

    2 hours

Study Arms (1)

intervention

EXPERIMENTAL

intervention given

Other: salt

Interventions

saltOTHER

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).

intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Kidney disease, Cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Livingstone University Teaching Hospital

Livingstone, Southern Province, 10101, Zambia

NOT YET RECRUITING

Kanyama General Hospital

Lusaka, 10101, Zambia

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Salts

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Central Study Contacts

Sepiso K Masenga, PhD

CONTACT

+260977674774sepisomasenga@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 26, 2024

Study Start

July 7, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Data set and manuscripts published

Shared Documents
CSR
Time Frame
2025
Access Criteria
email

Locations

ZA(2)