Acute Salt Sensitivity of Blood Pressure | NCT04844255

Studies
Acute Salt Sensitivity of Blood Pressure

NCT04844255

Sponsor

Mulungushi University

Status

Completed

Last Update Posted

Apr 15, 2021Actual

Enrollment

132Actual

Phase

Not Applicable

Conditions

Blood Pressure

Interventions

dietary salt

Countries

Zambia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Apr 9, 2021

First Submission Date that Met QC Criteria

Apr 9, 2021

First Posted Date

Apr 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 15, 2021Actual

Name	Class
University of Zambia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pre and post intervention group	Other	Same individuals are examined before and after taking 2 tablets of salt	Dietary Supplement: dietary salt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dietary salt	Dietary Supplement	2 grams of dietary salt	Pre and post intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sepiso K Masenga, PhD	Mulungushi University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Livingstone Central Hospital		Livingstone	Southern Province	10101	Zambia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38524849	Derived	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.

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals