NCT04844255

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 9, 2021

Last Update Submit

April 13, 2021

Conditions

Keywords

salt sensitivitysaltacute salt sensitivityBlood pressureMean arterial pressure

Outcome Measures

Primary Outcomes (1)

  • Acute salt sensitivity

    Mean arterial pressure change of 10 mmHg

    160 minutes

Secondary Outcomes (2)

  • Diastolic blood pressure change

    160 minutes

  • Systolic blood pressure change

    160 minutes

Study Arms (1)

Pre and post intervention group

OTHER

Same individuals are examined before and after taking 2 tablets of salt

Dietary Supplement: dietary salt

Interventions

dietary saltDIETARY_SUPPLEMENT

2 grams of dietary salt

Pre and post intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • diabetes patients, ill participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Livingstone Central Hospital

Livingstone, Southern Province, 10101, Zambia

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Sepiso K Masenga, PhD

    Mulungushi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Time series design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 14, 2021

Study Start

December 1, 2020

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After publishing results
Access Criteria
email and published article (open access)

Locations