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    Clinical Trial Results:
    Vitamin D And Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention - A European multicentre, randomised trial: Vitamin D limb.

    Summary
    EudraCT number
    2013-000789-13
    Trial protocol
    AT   BE  
    Global end of trial date
    31 Jan 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Sep 2016
    First version publication date
    04 Sep 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    Trial_version1
    Additional study identifiers
    ISRCTN number
    ISRCTN70595832
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    VU University Medical Center
    Sponsor organisation address
    van der Boechorststraat 7, Amsterdam, Netherlands, 1081 BT
    Public contact
    Trial Coordinator, Cambridge University Hospitals NHS Foundation Trust, +61 246203899, da.simmons@westernsydney.edu.au
    Scientific contact
    Trial Coordinator, Cambridge University Hospitals NHS Foundation Trust, +61 246203899, da.simmons@westernsydney.edu.au
    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
    31 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To identify the best available measures to prevent GDM in an ongoing pregnancy 2) Comparison of the impact of increased physical activity, enhanced nutrition and Vitamin D supplementation either alone or in combination on maternal glucose tolerance, maternal weight gain and insulin sensitivity
    Protection of trial subjects
    Before inclusion and during the intervention, participants were screened for hypercalciuria (≥2.27 mmol/mmol calcium/creatinine) and hypercalcaemia (at 24–28 weeks >9.0 mg/dl | 2.25 mmol/l; and at 35–37 weeks > 9.7 mg/dl |2.43 mmol/l). With blood levels exceeding these values, the intervention was stopped.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Mar 2013
    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
    Austria: 25
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Italy: 22
    Country: Number of subjects enrolled
    United Kingdom: 41
    Country: Number of subjects enrolled
    Ireland: 15
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    Poland: 20
    Worldwide total number of subjects
    154
    EEA total number of subjects
    154
    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)
    154
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment took place in 7 European countries (United Kingdom, Ireland, Austria, Poland, Italy (Padua, Pisa), Spain, and Belgium) from March 2013-July 2015.

    Pre-assignment
    Screening details
    Screening for existing GDM using IADPSG/WHO 2013 criteria (fasting venous plasma glucose ≥ 5.1 mmol/l and/or 1 hour glucose ≥10 mmol/l and/or 2 hour glucose ≥ 8.5 mmol/l).

    Period 1
    Period 1 title
    < 20 weeks of gestation
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Healthy eating and physical activity and placebo
    Arm description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.
    Arm type
    Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 IU per tablet. Participants are requested to take 4 tablets per day.

    Arm title
    Vitamin D
    Arm description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)
    Arm type
    Experimental

    Investigational medicinal product name
    vitamin D
    Investigational medicinal product code
    A11CC05
    Other name
    Devaron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taking into account that most women use multivitamins during pregnancy, containing on average 400 IU vitamin D, we chose to use a dosage of 1600 IU/day as the intervention dosage in our trial, in tablet form, Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766). Each tablet contains 400 IU, and participants are asked to take 4 tablets/day until delivery. Devaron is prepacked in bottles containing 90 tablets each.

    Arm title
    vitaminD&HE&PA
    Arm description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.
    Arm type
    Active comparator

    Investigational medicinal product name
    vitamin D
    Investigational medicinal product code
    A11CC05
    Other name
    Devaron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taking into account that most women use multivitamins during pregnancy, containing on average 400 IU vitamin D, we chose to use a dosage of 1600 IU/day as the intervention dosage in our trial, in tablet form, Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766). Each tablet contains 400 IU, and participants are asked to take 4 tablets/day until delivery. Devaron is prepacked in bottles containing 90 tablets each.

    Arm title
    Placebo
    Arm description
    Placebo tablets identical to the vitamin D tablets
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 IU per tablet. Participants are requested to take 4 tablets per day.

    Number of subjects in period 1
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Started
    38
    42
    37
    37
    Completed
    38
    42
    37
    37
    Period 2
    Period 2 title
    24-28 weeks of gestation
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Healthy eating and physical activity and placebo
    Arm description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.
    Arm type
    Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 IU per tablet. Participants are requested to take 4 tablets per day.

    Arm title
    Vitamin D
    Arm description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)
    Arm type
    Experimental

    Investigational medicinal product name
    vitamin D
    Investigational medicinal product code
    A11CC05
    Other name
    Devaron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taking into account that most women use multivitamins during pregnancy, containing on average 400 IU vitamin D, we chose to use a dosage of 1600 IU/day as the intervention dosage in our trial, in tablet form, Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766). Each tablet contains 400 IU, and participants are asked to take 4 tablets/day until delivery. Devaron is prepacked in bottles containing 90 tablets each.

    Arm title
    vitaminD&HE&PA
    Arm description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.
    Arm type
    Active comparator

    Investigational medicinal product name
    vitamin D
    Investigational medicinal product code
    A11CC05
    Other name
    Devaron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taking into account that most women use multivitamins during pregnancy, containing on average 400 IU vitamin D, we chose to use a dosage of 1600 IU/day as the intervention dosage in our trial, in tablet form, Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766). Each tablet contains 400 IU, and participants are asked to take 4 tablets/day until delivery. Devaron is prepacked in bottles containing 90 tablets each.

    Arm title
    Placebo
    Arm description
    Placebo tablets identical to the vitamin D tablets
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 IU per tablet. Participants are requested to take 4 tablets per day.

    Number of subjects in period 2
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Started
    38
    42
    37
    37
    Completed
    32
    42
    35
    34
    Not completed
    6
    0
    2
    3
         Study takes too much time
    4
    -
    -
    1
         miscarriage
    -
    -
    1
    1
         Consent withdrawn by subject
    1
    -
    -
    -
         Lost to follow-up
    1
    -
    1
    1
    Period 3
    Period 3 title
    35-37 weeks of gestation
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Healthy eating and physical activity and placebo
    Arm description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.
    Arm type
    Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 iU per tablet. Participants are requested to take 4 tablets per day.

    Arm title
    Vitamin D
    Arm description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)
    Arm type
    Experimental

    Investigational medicinal product name
    vitamin D
    Investigational medicinal product code
    A11CC05
    Other name
    Devaron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taking into account that most women use multivitamins during pregnancy, containing on average 400 IU vitamin D, we chose to use a dosage of 1600 IU/day as the intervention dosage in our trial, in tablet form, Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766). Each tablet contains 400 IU, and participants are asked to take 4 tablets/day until delivery. Devaron is prepacked in bottles containing 90 tablets each.

    Arm title
    vitaminD&HE&PA
    Arm description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.
    Arm type
    Active comparator

    Investigational medicinal product name
    vitamin D
    Investigational medicinal product code
    A11CC05
    Other name
    Devaron
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taking into account that most women use multivitamins during pregnancy, containing on average 400 IU vitamin D, we chose to use a dosage of 1600 IU/day as the intervention dosage in our trial, in tablet form, Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766). Each tablet contains 400 IU, and participants are asked to take 4 tablets/day until delivery. Devaron is prepacked in bottles containing 90 tablets each.

    Arm title
    Placebo
    Arm description
    Placebo tablets identical to the vitamin D tablets
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 IU per tablet. Participants are requested to take 4 tablets per day.

    Number of subjects in period 3
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Started
    32
    42
    35
    34
    Completed
    28
    37
    32
    31
    Not completed
    4
    5
    3
    3
         unknown
    2
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    1
         Lost to follow-up
    2
    5
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Healthy eating and physical activity and placebo
    Reporting group description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.

    Reporting group title
    Vitamin D
    Reporting group description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)

    Reporting group title
    vitaminD&HE&PA
    Reporting group description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets identical to the vitamin D tablets

    Reporting group values
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo Total
    Number of subjects
    38 42 37 37 154
    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 at recruitment
    Units: years
        arithmetic mean (standard deviation)
    33.1 ± 5.3 31.8 ± 5.1 33 ± 5.4 32.5 ± 5.6 -
    Gender categorical
    Units: Subjects
        Female
    38 42 37 37 154
        Male
    0 0 0 0 0
    Multiparous
    Women had a previous baby
    Units: Subjects
        Nulliparous
    15 23 15 17 70
        Multiparous
    23 19 22 20 84

    End points

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    End points reporting groups
    Reporting group title
    Healthy eating and physical activity and placebo
    Reporting group description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.

    Reporting group title
    Vitamin D
    Reporting group description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)

    Reporting group title
    vitaminD&HE&PA
    Reporting group description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets identical to the vitamin D tablets
    Reporting group title
    Healthy eating and physical activity and placebo
    Reporting group description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.

    Reporting group title
    Vitamin D
    Reporting group description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)

    Reporting group title
    vitaminD&HE&PA
    Reporting group description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets identical to the vitamin D tablets
    Reporting group title
    Healthy eating and physical activity and placebo
    Reporting group description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.

    Reporting group title
    Vitamin D
    Reporting group description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)

    Reporting group title
    vitaminD&HE&PA
    Reporting group description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets identical to the vitamin D tablets

    Primary: Gestational weight gain

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    End point title
    Gestational weight gain
    End point description
    Maternal gestational weight gain isbe defined as the weight change from baseline measurement to the last measurement at 35–37 weeks of gestation.
    End point type
    Primary
    End point timeframe
    35-37 weeks
    End point values
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Number of subjects analysed
    30
    37
    33
    32
    Units: kg
        arithmetic mean (standard deviation)
    7.78 ± 4.25
    7.42 ± 4.74
    8.43 ± 5.17
    8.09 ± 7.33
    Statistical analysis title
    Factorial weight gain
    Statistical analysis description
    Both vitamin D arms were combined and compared with the combined placebo groups, regardless of lifestyle intervention (using the factorial design) since no interaction was present between the two intervention modalities.
    Comparison groups
    Placebo v Healthy eating and physical activity and placebo v Vitamin D v vitaminD&HE&PA
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Regression, Linear
    Parameter type
    Slope
    Point estimate
    -1.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.66
         upper limit
    0.6

    Primary: Fasting glucose

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    End point title
    Fasting glucose
    End point description
    End point type
    Primary
    End point timeframe
    24-28 weeks
    End point values
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Number of subjects analysed
    32
    42
    33 [1]
    33 [2]
    Units: mmol/l
        arithmetic mean (standard deviation)
    4.76 ± 0.53
    4.57 ± 0.41
    4.67 ± 0.38
    4.64 ± 0.44
    Notes
    [1] - No blood sample from 3 women
    [2] - no blood sample from one woman
    Statistical analysis title
    Factorial fasting glucose
    Comparison groups
    Healthy eating and physical activity and placebo v Vitamin D v vitaminD&HE&PA v Placebo
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Regression, Linear
    Parameter type
    Slope
    Point estimate
    -0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    0.04

    Primary: Insulin sensitivity

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    End point title
    Insulin sensitivity
    End point description
    End point type
    Primary
    End point timeframe
    24-28 weeks
    End point values
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Number of subjects analysed
    32
    42
    33 [3]
    33 [4]
    Units: HOMA index
        median (inter-quartile range (Q1-Q3))
    2.83 (2.03 to 4.5)
    2.85 (2.27 to 4.16)
    3.11 (2.22 to 4.01)
    2.88 (2.08 to 4.07)
    Notes
    [3] - OGTT not succesful in 2 women
    [4] - OGTT not succesful in one woman
    Statistical analysis title
    Factorial HOMA
    Statistical analysis description
    Both vitamin D arms were combined and compared with the two combined placebo groups, regardless of lifestyle intervention (using the factorial design) since no interaction was present between the two intervention modalities.
    Comparison groups
    Placebo v Healthy eating and physical activity and placebo v Vitamin D v vitaminD&HE&PA
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Regression, Linear
    Parameter type
    Slope
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.21

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline till 7 days after delivery
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Healthy eating and physical activity and placebo
    Reporting group description
    Women received 5 face-to-face and up to 4 telephone coaching sessions on healty eating and physical activity, based on the principles of motivational interviewing. In addition, placebo tablets identical to the vitamin D tablets.

    Reporting group title
    Vitamin D
    Reporting group description
    1600 IU/day vitamin D in tablet form: Devaron®, produced by Vemedia (Diemen, Netherlands) (RVG 09766)

    Reporting group title
    vitaminD&HE&PA
    Reporting group description
    vitamin D (1600 IU/day) as in Arm 2 combined with counseling on healthy eating (HE) and physcial activity (PA) as in Arm 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets identical to the vitamin D tablets

    Serious adverse events
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 42 (7.14%)
    2 / 37 (5.41%)
    1 / 37 (2.70%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    High blood pressure
    Additional description: Hospitalisation for 5 days with raised blood pressure
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Large vessel transposition
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal atresia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    miscarriage
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    blood loss
    Additional description: Hospitalised for 7 days with unstable lie and had PPH of 1500 mls at LSCS.
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Maternal fever
    Additional description: Suspected neonatal sepsis after maternal fever during labour
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Healthy eating and physical activity and placebo Vitamin D vitaminD&HE&PA Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 38 (34.21%)
    25 / 42 (59.52%)
    20 / 37 (54.05%)
    18 / 37 (48.65%)
    Vascular disorders
    Pregnancy induced hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 38 (2.63%)
    6 / 42 (14.29%)
    3 / 37 (8.11%)
    2 / 37 (5.41%)
         occurrences all number
    1
    6
    3
    2
    Pregnancy, puerperium and perinatal conditions
    Caesarean section
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 38 (31.58%)
    19 / 42 (45.24%)
    17 / 37 (45.95%)
    16 / 37 (43.24%)
         occurrences all number
    12
    19
    17
    16

    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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