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    Clinical Trial Results:
    The Effect of Selenium Supplementation on Musculoskeletal Health in Older Women - Double-blind, randomised, placebo-controlled trial

    Summary
    EudraCT number
    		 2016-002964-15
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    STH19102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02832648
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 clincal trials.gov: NCT02832648 , Funder Reference: NIHR EME 14-200-20
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    Trust Headquarters, 8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    Scientific contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    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
    06 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Objective: to determine if selenium supplementation is beneficial for osteoporosis prevention and muscle function in postmenopausal women
    Protection of trial subjects
    All participants were given a participant information sheet to read and consider for at least 24 hours before attending for a screening visit for the study. Participants were reviewed by a clinician who was delegated to this task, according to the strict inclusion and exclusion criteria. All participants give written informed consent prior to enrolment to the study. An assessment of radiation exposure was performed by the Radiation Protection Advisor for the Sheffield Teaching Hospitals NHS Foundation Trust prior to ethical review of the project. GCP procedures were in place to ensure appropriate consent, confidentiality and privacy. Data were handled in accordance with the Data Protection Act.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jan 2017
    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
    United Kingdom: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    50
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were identified from AUBM volunteer database, Metabolic Bone Centre, Northern General Hospital, posters/email/website/word of mouth. All volunteers who passed pre-eligibility checks and attended for consent and screening were registered and allocated a study screening number.

    Pre-assignment
    Screening details
    		 Medical history for inclusion/exclusion criteria, BMD spine and hip by DXA, Blood tests –for diabetes mellitus, thyroid dysfunction, bone profile, Eligibility was confirmed by the PI or delegated medical practitioner.

    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, Assessor
    Blinding implementation details
    The active treatment was overencapsulated and a matched placebo manufactured to maintain the blind.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Selenase 50mcg
    Arm description
    		 Selenium 50mcg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selenase 50mcg
    Investigational medicinal product code
    Other name
    Selenium
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mcg per day for 6 months

    Arm title
    		 Selenase 200mcg
    Arm description
    		 Selenium 200mcg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selenase 200mcg
    Investigational medicinal product code
    Other name
    Selenium
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mcg per day for 6 months

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet once a day for 6 months

    Number of subjects in period 1
    		Selenase 50mcg Selenase 200mcg Placebo
    Started
    40
    40
    40
    Completed
    39
    39
    37
    Not completed
    1
    1
    3
         Consent withdrawn by subject
    1
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Selenase 50mcg
    Reporting group description
    		 Selenium 50mcg

    Reporting group title
    Selenase 200mcg
    Reporting group description
    		 Selenium 200mcg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Selenase 50mcg Selenase 200mcg Placebo Total
    Number of subjects
    		 40 40 40 120
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.7 ( 6.1 ) 64.5 ( 6.1 ) 66.6 ( 6.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 40 40 40 120
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Selenase 50mcg
    Reporting group description
    		 Selenium 50mcg

    Reporting group title
    Selenase 200mcg
    Reporting group description
    		 Selenium 200mcg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Between-group difference in urinary N-telopeptide of type I collagen (NTX) at 26 weeks

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    End point title
    		 Between-group difference in urinary N-telopeptide of type I collagen (NTX) at 26 weeks
    End point description
    Between-group difference in urinary N-telopeptide of type I collagen (NTX) at 26 weeks. We chose NTX because we know how change in NTX relates to fracture risk reduction with bisphosphonates (20): a 30% decrease in NTX is associated with a 40% reduction in spine fracture and 66% of the vertebral fracture risk reduction at three years is explained by change in NTX.
    End point type
    Primary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    35
    37
    34
    Units: nmol bone collagen equiv:mmol creatinine
        arithmetic mean (confidence interval 95%)
    43.4 (37.4 to 50.5)
    42.2 (37.5 to 47.6)
    40.5 (34.9 to 47.0)
    Statistical analysis title
    		 50 mcg vs placebo
    Statistical analysis description
    Primary endpoint analysis was the between-group difference in urine NTx to creatinine ratio at 26 weeks. Analysis of covariance was used with 26-week NTx to creatinine measurement as the dependent outcome variable and treatment group and baseline NTx to creatinine measurement as the independent variables. If the residuals from the model were not normally distributed, the values would be log transformed and the treatment group differences back transformed to be presented as a ratio.
    Comparison groups
    Placebo v Selenase 50mcg
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.74 [1]
    Method
    		 ANCOVA
    Parameter type
    		 ratio of means
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.19
    Notes
    [1] - no significant difference across the three arms
    Statistical analysis title
    		 200 mcg vs placebo
    Statistical analysis description
    Primary endpoint analysis was the between-group difference in urine NTx to creatinine ratio at 26 weeks. Analysis of covariance was used with 26-week NTx to creatinine measurement as the dependent outcome variable and treatment group and baseline NTx to creatinine measurement as the independent variables. If the residuals from the model were not normally distributed, the values would be log transformed and the treatment group differences back transformed to be presented as a ratio.
    Comparison groups
    Selenase 200mcg v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.66
    Method
    		 ANCOVA
    Parameter type
    		 ratio of means
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.12
    Statistical analysis title
    		 200 mcg vs 50 mcg
    Statistical analysis description
    Primary endpoint analysis was the between-group difference in urine NTx to creatinine ratio at 26 weeks. Analysis of covariance was used with 26-week NTx to creatinine measurement as the dependent outcome variable and treatment group and baseline NTx to creatinine measurement as the independent variables. If the residuals from the model were not normally distributed, the values would be log transformed and the treatment group differences back transformed to be presented as a ratio.
    Comparison groups
    Selenase 50mcg v Selenase 200mcg
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.43
    Method
    		 ANCOVA
    Parameter type
    		 ratio of means
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.09

    Secondary: serum selenium

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    End point title
    		 serum selenium
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    37
    39
    33
    Units: mcg/l
        arithmetic mean (confidence interval 95%)
    96.2 (90.7 to 101.6)
    105.7 (99.5 to 111.9)
    77.7 (73.3 to 82.2)
    No statistical analyses for this end point

    Secondary: serum selenoprotein P

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    End point title
    		 serum selenoprotein P
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    37
    39
    33
    Units: mg/l
        arithmetic mean (confidence interval 95%)
    6.25 (5.79 to 6.7)
    6.03 (5.54 to 6.51)
    5.31 (4.75 to 5.87)
    No statistical analyses for this end point

    Secondary: serum procollagen type I N propeptide (PINP)

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    End point title
    		 serum procollagen type I N propeptide (PINP)
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    37
    37
    34
    Units: mcg/l
        geometric mean (confidence interval 95%)
    46.8 (41 to 53.3)
    47.0 (41.3 to 53.6)
    47 (42.5 to 52)
    No statistical analyses for this end point

    Secondary: serum osteocalcin

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    End point title
    		 serum osteocalcin
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    37
    37
    34
    Units: mcg/l
        geometric mean (confidence interval 95%)
    14.1 (12.3 to 16.2)
    13.9 (12.4 to 15.6)
    14.4 (12.6 to 16.4)
    No statistical analyses for this end point

    Secondary: serum C–terminal cross-linking telopeptide of type I collagen (CTX)

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    End point title
    		 serum C–terminal cross-linking telopeptide of type I collagen (CTX)
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    37
    37
    34
    Units: mcg/l
        geometric mean (confidence interval 95%)
    0.12 (0.09 to 0.16)
    0.11 (0.09 to 0.15)
    0.13 (0.09 to 0.17)
    No statistical analyses for this end point

    Secondary: total hip bone mineral density by DXA

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    End point title
    		 total hip bone mineral density by DXA
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    38
    39
    34
    Units: g/cmsq
        arithmetic mean (confidence interval 95%)
    -1.2 (-1.4 to -1.0)
    -0.9 (-1.1 to -0.7)
    -1.2 (-1.5 to -1.0)
    No statistical analyses for this end point

    Secondary: lumbar spine bone mineral density by DXA

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    End point title
    		 lumbar spine bone mineral density by DXA
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    37
    37
    34
    Units: g/cmsq
        arithmetic mean (confidence interval 95%)
    -1.8 (-2.1 to -1.5)
    -1.9 (-2.1 to -1.7)
    -1.8 (-2.1 to -1.5)
    No statistical analyses for this end point

    Secondary: short physical performance battery

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    End point title
    		 short physical performance battery
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    38
    39
    36
    Units: score /12
        number (confidence interval 95%)
    10.4 (9.9 to 10.9)
    10.3 (9.7 to 10.8)
    10.9 (10.5 to 11.4)
    No statistical analyses for this end point

    Secondary: grip strength dominant hand

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    End point title
    		 grip strength dominant hand
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    36
    39
    36
    Units: kg
        arithmetic mean (confidence interval 95%)
    18.9 (17.4 to 20.4)
    18.4 (16.9 to 19.8)
    18.1 (16.6 to 19.5)
    No statistical analyses for this end point

    Secondary: glutathione peroxidase activity

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    End point title
    		 glutathione peroxidase activity
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    37
    39
    33
    Units: IU/l
        arithmetic mean (confidence interval 95%)
    176.8 (149.2 to 204.3)
    160.1 (132.4 to 187.8)
    175.4 (147.5 to 203.2)
    No statistical analyses for this end point

    Secondary: serum highly sensitive c-reactive protein

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    End point title
    		 serum highly sensitive c-reactive protein
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Selenase 50mcg Selenase 200mcg Placebo
    Number of subjects analysed
    33
    37
    35
    Units: mg/l
        geometric mean (confidence interval 95%)
    0.81 (0.58 to 1.13)
    1.09 (0.74 to 1.60)
    1.31 (0.88 to 1.94)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The reporting period for adverse events was from the date of informed consent until 28 days after the last administration of IMP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    All enrolled
    Reporting group description
    		 -

    Serious adverse events
    		 All enrolled
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 120 (2.50%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon Cancer
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Left Deep Vein Thrombosis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac ischaemia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All enrolled
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 120 (66.67%)
    Surgical and medical procedures
    Removal of wisdom teeth
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Foot surgery
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Joint replacement (excl hip and knee)
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    General disorders and administration site conditions
    Swelling of legs
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    2
    Chest pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Sinus pain
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    3
    Cough
         subjects affected / exposed
    5 / 120 (4.17%)
         occurrences all number
    5
    Sore throat
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    COPD exacerbation
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Asthmatic attack
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Psychiatric disorders
    Low mood
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Investigations
    Raised blood pressure
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 120 (4.17%)
         occurrences all number
    6
    Baker's cyst ruptured
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Laceration of leg
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Whiplash injury
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Pulled muscle
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Insect bite
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Bee sting
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Fracture rib1
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Sprained ankle
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Cardiac disorders
    Angina
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Taste metallic
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Trapped nerve
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Syncope vasovagal
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Eye disorders
    Eye floaters
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    Stomachache
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    4
    Dry mouth
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Saliva secretion excessive
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Mouth ulcer
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Gastroesophageal reflux
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Rectal polyp
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Discolouration nail
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Blister of hip, thigh, leg, and ankle, without mention of infection
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Hair thinning
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Splitting nails
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Hives
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Renal and urinary disorders
    Urgency urination
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Urination frequency of
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    kidney stone
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Renal artery aneurysm
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Aching joints
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    Trigger thumb
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Plantar fasciitis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Jaw pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Swelling of elbows
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Back muscle spasms
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Pain in (r) shoulder
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Leg pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Knee pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Pain in thumb
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Pain foot
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Cold
         subjects affected / exposed
    15 / 120 (12.50%)
         occurrences all number
    18
    Urinary tract infection
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    Ear infection
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Throat infection
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Chest infection
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    Shingles
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Knee pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Streptococcus pneumoniae pneumonia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    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.
    Intended to measure hydroperoxidases as a marker of reactive oxygen species but assay was withdrawn.Most IL6 measurements were below the limit of detection of 1.6ng/l (74/110 at base, 71/110 at w13 and 74/108 at w26), no further analysis conducted.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33842907
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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