NCT06022133

Brief Summary

A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

January 3, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

April 23, 2020

Last Update Submit

August 28, 2023

Conditions

Sodium ImbalanceNocturnal Blood PressureObstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

  • Changes in nocturnal systolic blood pressure

    Comparison of blood pressure measured by 24 hour blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)

    from day 14 to day 28

Secondary Outcomes (5)

  • Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)

    from day 14 to day 28

  • Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)

    from day 14 to day 28

  • Changes in day:night sodium urinary sodium excretion

    from day 14 to day 28

  • Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)

    from day 14 to day 28

  • Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)

    from day 14 to day 28

Study Arms (2)

Dietary sodium restriction

EXPERIMENTAL

DIetary sodium restriction

Behavioral: Dietary sodium restriction

Usual diet

NO INTERVENTION

Usual diet

Interventions

Dietary sodium restrictionBEHAVIORAL

Selfemployed dietary sodium restriction

Dietary sodium restriction

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • h blood pressure \> 130/80 mmHg under antihypertensive treatment with three agent, one of these being diuretic. Blood pressure measurement completed after observed intake of antihypertensive medication.
  • unchanged antihypertensive treatment for three months
  • estimated glomerular function \>45 mL/min/1.73 m2

You may not qualify if:

  • Heart failure assessed from NYHA classification (grade 3-4)
  • Presence of clinically significant peripheral edema
  • In treatment for obstructive sleep apnea
  • Chronic obstructive pulmonary disease (FEV1 \<50%)
  • Antihypertensive therapy that can not be taken once daily
  • Pregnancy or breastfeeding
  • Β-albumin \<34 g / l
  • U-albumin creatinine ratio\> 1000 mg / g
  • INR\> 1.2 (if marevan treatment: ALAT\> 200)
  • Gluten allergy (dietary guidelines are not adjusted to this group)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University clinic in Nephrology and hypertension, Regional Hospital Godstrup

Gødstrup, Herning, 7400, Denmark

Location

Department of Medical Research and Medicine, Holstebro Regional Hospital

Holstebro, 7500, Denmark

Location

Related Publications (1)

  • Hornstrup BG, Hoffmann-Petersen N, Lauridsen TG, Bech JN. Dietary sodium restriction reduces blood pressure in patients with treatment resistant hypertension. BMC Nephrol. 2023 Sep 19;24(1):274. doi: 10.1186/s12882-023-03333-9.

    PMID: 37726656DERIVED

Study Officials

  • Bodil Hornstrup

    M.D., Ph.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Binding not possible as patients needs to carry out dietary sodium restriction themselves.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., PhD, head of University Clinic in Nephrology and Hypertension, Regeional Hospital Vest Justland and Aarhus university

Study Record Dates

First Submitted

April 23, 2020

First Posted

September 1, 2023

Study Start

January 3, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)