Immediate Pressor Response to Oral Salt

NCT ID: NCT06226636

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-07

Study Completion Date

2025-12-31

Brief Summary

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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)

Detailed Description

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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

Conditions

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High Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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intervention

intervention given

Group Type EXPERIMENTAL

salt

Intervention Type OTHER

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).

Interventions

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salt

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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Kidney disease, Cardiovascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mulungushi University

OTHER

Sponsor Role lead

Responsible Party

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Sepiso K. Masenga

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Livingstone University Teaching Hospital

Livingstone, Southern Province, Zambia

Site Status NOT_YET_RECRUITING

Kanyama General Hospital

Lusaka, , Zambia

Site Status RECRUITING

Countries

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Zambia

Central Contacts

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Sepiso K Masenga, PhD

Role: CONTACT

+260977674774

Facility Contacts

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Kaseya Chiyenu, MD

Role: primary

Chileleko Siakabanze, MSc

Role: primary

Other Identifiers

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IPROS

Identifier Type: -

Identifier Source: org_study_id

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