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    Clinical Trial Results:
    Combined effects of potassium, nitrate and sodium on blood pressure in patients with hypertension

    Summary
    EudraCT number
    		 2021-003407-17
    Trial protocol
    		 DK  
    Global end of trial date
    24 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2025
    First version publication date
    22 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLD-1-2021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regionshospitalet Gødstrup
    Sponsor organisation address
    Hospitalsparken 15, Herning, Denmark, 7400
    Public contact
    Camilla Lundgreen Duus, University Clinic in Nephrology and Hypertension, 0045 78432390, camduu@rm.dk
    Scientific contact
    Camilla Lundgreen Duus, University Clinic in Nephrology and Hypertension, 0045 78432390, camduu@rm.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Aug 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is investigating the effect of dietary potassium, nitrate and salt on blood pressure in patients with essential hypertension
    Protection of trial subjects
    All patients had direct phone number to a medical doctor during the entire study, and could contact her 24/7. If symptoms occured and blood pressure was high, patients were excluded from the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 92
    Worldwide total number of subjects
    92
    EEA total number of subjects
    92
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    45
    From 65 to 84 years
    47
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from local newspapers, local general practioners or from participants i previous studies in our department.

    Pre-assignment
    Screening details
    		 123 participants were screened, 111 included, 96 randomized and 90 completed the study. The screening process consisted of medical history, medical examination, blood pressure measurement, ECG, urine dip-stic, urine albumine/creatinine-ratio, blood samples (creatinine, eGFR, Na, K, Hemoglobin, albumin, ALAT, INR).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Low sodium (90 mmol), High potassium (125 mmol), low nitrate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Potassium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    1500 mg x 2

    Investigational medicinal product name
    Potassium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    1500 mg x 2

    Arm title
    		 Group B
    Arm description
    		 High sodium (210 mmol), high potassium (125 mmol), low nitrate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Potassium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    1500 mg x 2

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    7,5 g/day

    Arm title
    		 Group C
    Arm description
    		 High sodium (210 mmol), high potassium (125 mmol), high nitrate (13 mmol)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Potassium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    1500 mg x 2

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    7,5 g/day

    Investigational medicinal product name
    Beetroot juice with nitrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Enteral use
    Dosage and administration details
    75 ml beetroot juice with 6,5 mmol nitrate x 2 per day.

    Arm title
    		 Group D
    Arm description
    		 Low sodium (90 mmol), High potassium (125 mmol), high nitrate (13 mmol)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Potassium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    1500 mg x 2

    Investigational medicinal product name
    Beetroot juice with nitrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Enteral use
    Dosage and administration details
    75 ml beetroot juice with 6,5 mmol nitrate x 2 per day.

    Arm title
    		 Group E
    Arm description
    		 Low sodium (90 mmol), low potassium (85 mmol), low nitrate
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group F
    Arm description
    		 High sodium (210 mmol), high potassium (125 mmol), low nitrate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    7,5 g/day

    Investigational medicinal product name
    Potassium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    1500 mg x 2

    Arm title
    		 Group G
    Arm description
    		 High sodium (210 mmol), low potassium (85 mmol), high nitrate (13 mmol)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Beetroot juice with nitrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Enteral use
    Dosage and administration details
    75 ml beetroot juice with 6,5 mmol nitrate x 2 per day.

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    7,5 g/day

    Arm title
    		 Group H
    Arm description
    		 Low sodium (90 mmol), low potassium (85 mmol), high nitrate (13 mmol)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Beetroot juice with nitrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Enteral use
    Dosage and administration details
    75 ml beetroot juice with 6,5 mmol nitrate x 2 per day.

    Number of subjects in period 1
    		Group A Group B Group C Group D Group E Group F Group G Group H
    Started
    11
    11
    12
    11
    11
    12
    12
    12
    Completed
    11
    11
    12
    11
    11
    12
    11
    11
    Not completed
    0
    0
    0
    0
    0
    0
    1
    1
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Low sodium (90 mmol), High potassium (125 mmol), low nitrate

    Reporting group title
    Group B
    Reporting group description
    		 High sodium (210 mmol), high potassium (125 mmol), low nitrate

    Reporting group title
    Group C
    Reporting group description
    		 High sodium (210 mmol), high potassium (125 mmol), high nitrate (13 mmol)

    Reporting group title
    Group D
    Reporting group description
    		 Low sodium (90 mmol), High potassium (125 mmol), high nitrate (13 mmol)

    Reporting group title
    Group E
    Reporting group description
    		 Low sodium (90 mmol), low potassium (85 mmol), low nitrate

    Reporting group title
    Group F
    Reporting group description
    		 High sodium (210 mmol), high potassium (125 mmol), low nitrate

    Reporting group title
    Group G
    Reporting group description
    		 High sodium (210 mmol), low potassium (85 mmol), high nitrate (13 mmol)

    Reporting group title
    Group H
    Reporting group description
    		 Low sodium (90 mmol), low potassium (85 mmol), high nitrate (13 mmol)

    Reporting group values
    		 Group A Group B Group C Group D Group E Group F Group G Group H Total
    Number of subjects
    		 11 11 12 11 11 12 12 12 92
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ( 8.5 ) 67.2 ( 5.6 ) 65.1 ( 3.5 ) 60.2 ( 8.1 ) 61.4 ( 9.8 ) 63.6 ( 10.1 ) 62.6 ( 9 ) 62.5 ( 7.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 6 8 4 4 4 4 6 45
        Male
    		 2 5 4 7 7 8 8 6 47

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Low sodium (90 mmol), High potassium (125 mmol), low nitrate

    Reporting group title
    Group B
    Reporting group description
    		 High sodium (210 mmol), high potassium (125 mmol), low nitrate

    Reporting group title
    Group C
    Reporting group description
    		 High sodium (210 mmol), high potassium (125 mmol), high nitrate (13 mmol)

    Reporting group title
    Group D
    Reporting group description
    		 Low sodium (90 mmol), High potassium (125 mmol), high nitrate (13 mmol)

    Reporting group title
    Group E
    Reporting group description
    		 Low sodium (90 mmol), low potassium (85 mmol), low nitrate

    Reporting group title
    Group F
    Reporting group description
    		 High sodium (210 mmol), high potassium (125 mmol), low nitrate

    Reporting group title
    Group G
    Reporting group description
    		 High sodium (210 mmol), low potassium (85 mmol), high nitrate (13 mmol)

    Reporting group title
    Group H
    Reporting group description
    		 Low sodium (90 mmol), low potassium (85 mmol), high nitrate (13 mmol)

    Primary: Change in systolic 24-hour blood pressure

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    End point title
    		 Change in systolic 24-hour blood pressure
    End point description
    End point type
    Primary
    End point timeframe
    One week
    End point values
    		 Group A Group B Group C Group D Group E Group F Group G Group H
    Number of subjects analysed
    11
    11
    12
    11
    11
    12
    11
    11
    Units: mmHg
        arithmetic mean (standard deviation)
    -7 ( 7 )
    -1 ( 8 )
    5 ( 8 )
    -6 ( 5 )
    -8 ( 9 )
    -2 ( 7 )
    -2 ( 9 )
    -8 ( 9 )
    Statistical analysis title
    		 Fisher's exact t-test
    Statistical analysis description
    T-test performed in each group
    Comparison groups
    Group A v Group B v Group C v Group D v Group E v Group F v Group G v Group H
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.01 [1]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - Group A: p=0.01 Group B: p=0.8 Group C: p=0.08 Group D: p=0.005 Group E: p=0.02 Group F: p=0.28 Group G: p=0.46 Group H: o=0.02

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion to participant was terminated from the trial one week efter the last visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 92 (1.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Apoplectic stroke
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 92 (41.30%)
    Nervous system disorders
    Periodic headache
         subjects affected / exposed
    23 / 92 (25.00%)
         occurrences all number
    23
    Gastrointestinal disorders
    nausea/vomiting
         subjects affected / exposed
    13 / 92 (14.13%)
         occurrences all number
    13
    Loose stools
         subjects affected / exposed
    9 / 92 (9.78%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 May 2023
    Sodium chloride tablets out of stock.
    01 Nov 2023

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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