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    Clinical Trial Results:
    Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system

    Summary
    EudraCT number
    		 2013-004460-66
    Trial protocol
    		 DK  
    Global end of trial date
    21 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2020
    First version publication date
    15 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KARAASS-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02380157
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Jørgen Jeppesen
    Sponsor organisation address
    Valdemar Hansens Vej 1-23, Glostup, Denmark, 2600
    Public contact
    Rasmus Dreier, Rasmus Dreier, rasmus.dreier.01@regionh.dk
    Scientific contact
    Rasmus Dreier, Rasmus Dreier, rasmus.dreier.01@regionh.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
    24 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to test whether oral potassium supplementation, administered as Kaleorid, interacts with the renin-angiotensin-aldosterone system and the sympathetic nervous system.
    Protection of trial subjects
    Participants were treated with an oral potassium supplement (90 mmol potassium per day). To secure that hyperkalemia was not developed plasma potassium was systematically measured.
    Background therapy
    		 No background therapy. All participants were healthy men not taking any medication.
    Evidence for comparator
    		 We tested a potassium supplement (90 mmol per day) against placebo as the comparator, primarily to minimize bias.
    Actual start date of recruitment
    24 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited through announcement on the Danish website: www.forsoegsperson.dk, a website where researchers can announce their project for potential trial participants. Following recruitment a screening visit was arranged.

    Pre-assignment
    Screening details
    		 The screening consisted of a medical interview and baseline testing including physical examination, office blood pressure measurement, electrocardiogram and blood sampling. Only healthy normotensive men were included.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    Treatment was blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Potassium then Placebo
    Arm description
    		 Cross-over study. This arm received 4 weeks potassium supplement in period 1 followed by 4 weeks placebo in period 2. The two periods was separated by 2 weeks washout.
    Arm type
    		 Cross-over study

    Investigational medicinal product name
    Kaleorid, 750mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 tablets 3 times daily equivalent to 90 mmol potassium per day

    Arm title
    		 Placebo then Potassium
    Arm description
    		 Cross-over study. This arm received Placebo for 4 weeks in Period 1 followed by Potassium for 4 weeks in Period 2. The two periods was separated by 2 weeks washout.
    Arm type
    		 Cross-over study

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 tablets 3 times daily

    Number of subjects in period 1
    		Potassium then Placebo Placebo then Potassium
    Started
    16
    16
    Completed
    13
    12
    Not completed
    3
    4
         Adverse event, non-fatal
    1
    1
         Protocol deviation
    2
    3
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Treatment was blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Potassium then Placebo
    Arm description
    		 Cross-over study. This arm received 4 weeks potassium supplement in period 1 followed by 4 weeks placebo in period 2. The two periods was separated by 2 weeks washout.
    Arm type
    		 Cross-over study

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 tablets 3 times daily

    Arm title
    		 Placebo then Potassium
    Arm description
    		 Cross-over study. This arm received Placebo for 4 weeks in Period 1 followed by Potassium for 4 weeks in Period 2. The two periods was separated by 2 weeks washout.
    Arm type
    		 Cross-over study

    Investigational medicinal product name
    Kaleorid, 750mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 tablets 3 times daily equivalent to 90 mmol potassium per day

    Number of subjects in period 2
    		Potassium then Placebo Placebo then Potassium
    Started
    13
    12
    Completed
    13
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 Baseline characteristics are only for the 25 subjects who completed the study.

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 32 32
    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
    Age for the 25 men who completed the study
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 25.7 (23.1 to 34.4) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 32 32
    Body Mass Index (BMI)
    BMI of the 25 men who completed the study
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 24.8 ( 2.3 ) -
    Office Systolic Blood Pressure
    Office Systolic Blood Pressure of the 25 men who completed the study.
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 119.7 ( 6.9 ) -
    Office Diastolic Blood Pressure
    Office Diastolic Blood Pressure of the 25 men who completed the study.
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 72.6 ( 7.1 ) -
    Plasma Creatinine
    Plasma Creatinine of the 25 men who completed the study.
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    		 84.7 ( 12.3 ) -
    Plasma Sodium
    Plasma Sodium of the 25 men who completed the study.
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    		 142.1 ( 1.1 ) -
    Plasma Potassium
    Plasma Potassium of the 25 men who completed the study.
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    		 4.2 ( 0.2 ) -

    End points

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    End points reporting groups
    Reporting group title
    Potassium then Placebo
    Reporting group description
    		 Cross-over study. This arm received 4 weeks potassium supplement in period 1 followed by 4 weeks placebo in period 2. The two periods was separated by 2 weeks washout.

    Reporting group title
    Placebo then Potassium
    Reporting group description
    		 Cross-over study. This arm received Placebo for 4 weeks in Period 1 followed by Potassium for 4 weeks in Period 2. The two periods was separated by 2 weeks washout.
    Reporting group title
    Potassium then Placebo
    Reporting group description
    		 Cross-over study. This arm received 4 weeks potassium supplement in period 1 followed by 4 weeks placebo in period 2. The two periods was separated by 2 weeks washout.

    Reporting group title
    Placebo then Potassium
    Reporting group description
    		 Cross-over study. This arm received Placebo for 4 weeks in Period 1 followed by Potassium for 4 weeks in Period 2. The two periods was separated by 2 weeks washout.

    Subject analysis set title
    Crossover: Potassium
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Crossover study, We here report the results after 4 weeks on potassium.

    Subject analysis set title
    Crossover: Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Crossover study. We here report the results after 4 weeks on placebo.

    Primary: Angiotensin II stimulated P-aldosterone

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    End point title
    		 Angiotensin II stimulated P-aldosterone
    End point description
    Angiotensin II (Ang II) was infused in each subject and P-aldosterone was measured before, during and after the infusion. The aim was to test if the aldosterone respons to Ang II was different after 4 weeks on potassium compared with after 4 weeks on placebo. The result is presented as a graph.
    End point type
    Primary
    End point timeframe
    This was measured at the end of each treatment period, after 4 weeks on potassium and after 4 weeks on placebo.
    End point values
    		 Crossover: Potassium Crossover: Placebo
    Number of subjects analysed
    25
    25
    Units: pmol/L
        arithmetic mean (standard error)
    0 ( 0 )
    0 ( 0 )
    Attachments
    		 Angiotensin II stimulated P-Aldosterone
    Statistical analysis title
    		 Linear mixed model for repeated measurements
    Statistical analysis description
    In this analysis the effect of time was equal to the effect of the Ang II infusion, and if there was a significant interaction between time and treatment, then the response to Ang II was different between the two treatments (Potassium and Placebo).
    Comparison groups
    Crossover: Potassium v Crossover: Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Angiotensin II stimulated blood pressure (Systolic BP)

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    End point title
    		 Angiotensin II stimulated blood pressure (Systolic BP)
    End point description
    Angiotensin II (Ang II) was infused in each subject and systolic BP (blood pressure) was measured before, during and after the infusion. The aim was to test if the systolic BP response to Ang II was different after 4 weeks on potassium compared with after 4 weeks on placebo. The result is presented as a graph.
    End point type
    Secondary
    End point timeframe
    This was measured at the end of each treatment period, after 4 weeks on potassium and after 4 weeks on placebo.
    End point values
    		 Crossover: Potassium Crossover: Placebo
    Number of subjects analysed
    25
    25
    Units: mm Hg
        arithmetic mean (standard error)
    0 ( 0 )
    0 ( 0 )
    Attachments
    		 Angiotensin II stimulated systolic BP
    Statistical analysis title
    		 Linear mixed model for repeated measurements
    Statistical analysis description
    In this analysis the effect of time was equal to the effect of the Ang II infusion, and if there was a significant interaction between time and treatment, then the response to Ang II was different between the two treatments (Potassium and Placebo).
    Comparison groups
    Crossover: Potassium v Crossover: Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.885
    Method
    		 Mixed models analysis
    Confidence interval

    Other pre-specified: 24-hour SBP (systolic blood pressure)

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    End point title
    		 24-hour SBP (systolic blood pressure)
    End point description
    This endpoint is one of the 24-hour ambulatory blood pressure variables.
    End point type
    Other pre-specified
    End point timeframe
    This was measured at the end of each treatment period, after 4 weeks on potassium and after 4 weeks on placebo.
    End point values
    		 Crossover: Potassium Crossover: Placebo
    Number of subjects analysed
    25
    25
    Units: mm Hg
        arithmetic mean (standard deviation)
    117.6 ( 5.8 )
    118.2 ( 5.2 )
    Statistical analysis title
    		 Linear mixed model for repeated measurements
    Comparison groups
    Crossover: Potassium v Crossover: Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.48
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 1.1

    Other pre-specified: 24-hour DBP (diastolic blood pressure)

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    End point title
    		 24-hour DBP (diastolic blood pressure)
    End point description
    This end point is one of the 24-hour ambulatory blood pressure variables.
    End point type
    Other pre-specified
    End point timeframe
    This was measured at the end of each treatment period, after 4 weeks on potassium and after 4 weeks on placebo.
    End point values
    		 Crossover: Potassium Crossover: Placebo
    Number of subjects analysed
    25
    25
    Units: mm Hg
        arithmetic mean (standard deviation)
    70.8 ( 6.2 )
    70.8 ( 6.3 )
    Statistical analysis title
    		 Linear mixed model for repeated measurements
    Comparison groups
    Crossover: Potassium v Crossover: Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.97
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 1.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were registered for each individual from the first day of experimental treatment until their last visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None used
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Crossover: Potassium
    Reporting group description
    		 We here report adverse events during potassium treatment.

    Reporting group title
    Crossover: Placebo
    Reporting group description
    		 We here report adverse events during placebo treatment.

    Serious adverse events
    		 Crossover: Potassium Crossover: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Crossover: Potassium Crossover: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 25 (76.00%)
    17 / 25 (68.00%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 25 (16.00%)
         occurrences all number
    1
    4
    Abdominal pain
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 25 (12.00%)
         occurrences all number
    5
    3
    Flatulence
    Additional description: Flatus
         subjects affected / exposed
    9 / 25 (36.00%)
    5 / 25 (20.00%)
         occurrences all number
    9
    5
    Diarrhoea
    Additional description: Diarrhea
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Reflux gastritis
    Additional description: Acid reflux
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Itching
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Rash
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1

    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? No

    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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