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CompletedNCT05165823VASAUpdated Sep 22, 2023

The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients

An interventional study of Sodium restriction in Hypertension,Essential, sponsored by Regional Hospital Holstebro. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Regional Hospital Holstebro · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.

02

Conditions studied

  • Hypertension,Essential

Keywords

  • Salt sensitivity
  • Sodium sensitivity
  • Salt restriction
  • Salt-blood test
  • Dietary intervention
  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 72 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Regional Hospital Holstebro is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI ≤ 35 kg/m2
  • Essential hypertension
  • eGFR > 15 ml/min/1,73m2
  • Albumine-to-creatinine-ratio \< 500 mg/g
  • Safe anticonception if women in childbearing age.
  • Able to adhere to dietary regimen

Exclusion criteria

Exclusion Criteria:

  • Secondary hypertension
  • Clinically significant heart failure (NYHA 3-4)
  • Clinically significant liver disease
  • Diabetes mellitus (type 1 and 2)
  • Active cancer (except skin cancer)
  • Renal transplant
  • Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months)
  • Proliferative glomerulonephritis or ANCA-related disease
  • Continuous immunosuppressant treatment
  • Pregnancy or lactation
  • Alcohol abuse
  • If the investigator finds the participant unfit to complete the project
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Sodium restriction

    Behavioral: Sodium restriction

  • No intervention
    Usual diet

Interventions

  • BehavioralSodium restriction

    Participants will be guided in minimizing sodium intake. Guidance will be both oral and written. Bread with low sodium content will be offered to the participants.

06

What researchers measure

Primary outcomes

  1. Change in systolic 24-hour blood pressure

    Difference in systolic blood pressure measured before and after intervention

    Time frame: Measured before and after 4 weeks' intervention

07

Study locations

1 site
  • University Clinic in Nephrology and Hypertension
    Herning, 7400, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05165823
Lead sponsor
Regional Hospital Holstebro
Responsible party
Camilla Lundgreen Duus (Doctor, Ph.D.-student, Regional Hospital Holstebro) — Principal investigator
First posted
Dec 21, 2021
Start date
Feb 8, 2022
Primary completion
Jul 5, 2023
Completion
Jul 26, 2023
Last update
Sep 22, 2023

Study contacts

Camilla Lundgreen Duus
principal investigator · University Clinic in Nephrology and Hypertension

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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