NCT04755400

Brief Summary

Treatment with nitrate has shown to lower blood pressure in both healthy subjects and hypertensive patients.Beside this nitrate have also shown to decrease arterial stiffness and improve endothelial function.But the effect of nitrate on renal blood flow, kidney function, water and salt balance and vasoactive hormones is still unclear. Therefore, the purpose of this study is to investigate the effect of orally administered nitrate on these parameters. This will be done in a double-blinded, placebo-controlled, crossover study. 20 healthy subjects will be treated, in a randomized order, with both potassium nitrate and placebo separated by at least 4 weeks wash-out.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2018

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

September 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

February 3, 2021

Last Update Submit

February 17, 2021

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate (GFR)

    mL/minute

    analysed right after each examination day. (day 1)

Secondary Outcomes (25)

  • Brachial blood pressure (BP)

    analysed right after each examination day. (day 1)

  • central blood pressure (cSBP)

    analysed right after each examination day. (day 1)

  • Heart rate

    analysed right after each examination day. (day 1)

  • Pulse wave velocity (PWV)

    analysed right after each examination day. (day 1)

  • Total vascular resistance (TVR)

    analysed right after each examination day. (day 1)

  • +20 more secondary outcomes

Study Arms (2)

Potassium Nitrate

ACTIVE COMPARATOR

4 days treatment with 24 mmol potassium nitrate capsules

Other: isotonic saline 9%Dietary Supplement: Potassium nitrate

Potassium Chloride

PLACEBO COMPARATOR

4 days treatment 24 mmol potassium chloride capsules

Other: isotonic saline 9%Dietary Supplement: Potassium chloride

Interventions

isotonic saline 9%OTHER

1 Liter of Isotonic saline administered I.V.

Also known as: Sodium Chloride 9%
Potassium ChloridePotassium Nitrate
Potassium nitrateDIETARY_SUPPLEMENT

24 mmol of Potassium nitrate is the active comparator substance, that is ingested every morning for 4 days before and on the examination day.

Potassium Nitrate
Potassium chlorideDIETARY_SUPPLEMENT

24 mmol of Potassium nitrate is the placebo substance, that is ingested every morning for 4 days before and on the examination day.

Potassium Chloride

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-64 years
  • BMI 18,5-30
  • Normotensive
  • Women must use contraception

You may not qualify if:

  • Tobacco smoking (Non-smokers in more than 3 months can be included)
  • Medicine- or drug abuse
  • Alcohol abuse \>7 units for women \>14 units for men
  • Pregnancy or nursing
  • Neoplastic disorders
  • Significant clinical signs of heart-, lung-, liver-, kidney-, endocrine- or brain disorders
  • Clinically significant abnormal findings in screening blood samples, urine sample or ECG - Donation of blood within 1 month of the first day of investigation.
  • Allergy against compounds in investigational medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Godstrup Hospital

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Hypertension

Interventions

potassium nitratePotassium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Jesper N Bech, Ph.D., M.D.

    University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The Hospital Pharmacy, Herning Hospital, generates the randomization list. A copy of the list is kept at the Medical Research department. Patients are randomized to receive either potassium nitrate or placebo (Potassium chloride). The Hospital Pharmacy, Gødstrup Hospital, will blind both treatments.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: double-blinded, placebo-controlled, crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 16, 2021

Study Start

September 1, 2018

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

DK(1)