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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02112734
Registration number
NCT02112734
Ethics application status
Date submitted
10/04/2014
Date registered
14/04/2014
Date last updated
21/11/2023
Titles & IDs
Public title
Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2
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Scientific title
Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial
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Secondary ID [1]
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HREC # 34168 A
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Universal Trial Number (UTN)
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Trial acronym
VITALITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Food Allergy
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Condition category
Condition code
Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vitamin D
Treatment: Drugs - placebo
Active comparator: vitamin D - 400 IU /daily cholecalciferol/vitamin D
Placebo comparator: placebo - carrier formulation minus vitamin D
Treatment: Drugs: Vitamin D
400 IU/daily until age 12 months
Treatment: Drugs: placebo
identical placebo daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The prevalence of challenge-proven food allergy at 12 months of age
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Assessment method [1]
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The prevalence of challenge-proven food allergy at 12 months of age determined by a positive SPT and a positive oral food challenge
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Timepoint [1]
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At 12 months of age
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Primary outcome [2]
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The occurrence of definite food allergy or tolerance at 6 years of age
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Assessment method [2]
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The occurrence of definite food allergy or tolerance at 6 years of age can only be determined by combining data from an oral food challenge, a skin prick test (SPT) and/or serum specific IgE test, and/or parent/self-reported ingestion history and reactions to the index food.
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Timepoint [2]
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At 6 years of age
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Secondary outcome [1]
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The prevalence of food sensitisation at 12 months of age determined by SPT positive
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Assessment method [1]
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The prevalence of food sensitisation at 12 months of age determined by SPT positive
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Timepoint [1]
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At 12 months of age
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Secondary outcome [2]
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The prevalence of doctor diagnosed eczema during the first postnatal year
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Assessment method [2]
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The prevalence of doctor diagnosed eczema during the first postnatal year
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Timepoint [2]
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During the first postnatal year
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Secondary outcome [3]
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The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit
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Assessment method [3]
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The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D \<50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit
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Timepoint [3]
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At 12 months of age
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Secondary outcome [4]
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Allergy-related healthcare utilisation within the first 12 months of life
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Assessment method [4]
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Allergy-related healthcare utilisation within the first 12 months of life
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Timepoint [4]
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Within the first 12 months of life
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Secondary outcome [5]
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Infection episodes within the first 12 months of life
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Assessment method [5]
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Infection episodes within the first 12 months of life
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Timepoint [5]
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Within the first 12 months of life
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Secondary outcome [6]
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Measure of height at 12 months of age
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Assessment method [6]
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Measure of height at 12 months of age
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Timepoint [6]
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At 12 months of age
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Secondary outcome [7]
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Measure of weight at 12months of age
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Assessment method [7]
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Measure of weight at 12months of age
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Timepoint [7]
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At 12 months of age
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Secondary outcome [8]
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Wheeze episodes within the first 12 months of life
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Assessment method [8]
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Wheeze episodes within the first 12 months of life
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Timepoint [8]
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Within the first 12 months of life
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Secondary outcome [9]
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The occurrence of food sensitisation at 6 years of age determined by SPT positive
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Assessment method [9]
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The occurrence of food sensitisation at 6 years of age determined by SPT positive
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Timepoint [9]
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At 6 years of age
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Secondary outcome [10]
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The occurrence of asthma in the first 6 years of life
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Assessment method [10]
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The occurrence of asthma at 6 years of age
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Timepoint [10]
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At 6 years of age
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Secondary outcome [11]
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The occurrence of eczema in the first 6 years of life
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Assessment method [11]
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The occurrence of eczema in the first 6 years of life
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Timepoint [11]
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Within first 6 years of life
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Secondary outcome [12]
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The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 6 years determined by measuring blood taken at the 6 year clinic visit
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Assessment method [12]
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The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D \<50 nmol/L ) at age 6 years determined by measuring blood taken at the 6 year clinic visit
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Timepoint [12]
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At 6 years of age
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Secondary outcome [13]
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Allergy-related healthcare utilisation in the first 6 years of life
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Assessment method [13]
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Allergy-related healthcare utilisation in the first 6 years of life by data linkage from MBS and PBS
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Timepoint [13]
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Within first 6 years of life
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Secondary outcome [14]
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Measure of height at 6 years of age
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Assessment method [14]
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Measure of height at 6 years of age
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Timepoint [14]
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At 6 years of age
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Secondary outcome [15]
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Measure of Waist circumference at 6 years of age
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Assessment method [15]
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Measure of Waist circumference at 6 years of age
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Timepoint [15]
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At 6 years of age
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Secondary outcome [16]
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Measure of Hip circumference at 6 years of age
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Assessment method [16]
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Measure of Hip circumference at 6 years of age
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Timepoint [16]
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At 6 years of age
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Secondary outcome [17]
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Lung function at 6 years of age
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Assessment method [17]
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Lung function: bronchial responsiveness is measured using the percent change from baseline and absolute changes in forced expiratory volume (FEV) in 1 second and/or forced vital capacity (FVC) at 6 years of age
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Timepoint [17]
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At 6 years of age
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Secondary outcome [18]
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The occurrence of rhinitis in the first 6 years of life
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Assessment method [18]
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The occurrence of rhinitis in the first 6 years of life
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Timepoint [18]
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Within first 6 years of life
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Secondary outcome [19]
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Psychosocial Distress at 6 years of age
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Assessment method [19]
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Psychosocial health at 6 years of age by Kessler Psychological Distress Scale-10 (K-10) for parents The K10 scale involves 10 questions about emotional states each with a five-level response scale. Each item is scored from one 'none of the time' to five 'all of the time'. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
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Timepoint [19]
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At 6 years of age
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Secondary outcome [20]
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Psychosocial health at 6 years of age
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Assessment method [20]
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Psychosocial health at 6 years of age by Strengths and Difficulties Questionnaire (SDQ) for child
SDQ ask about 25 attributes, some positive and others negative.bThese 25 items are divided between 5 scales:
1. emotional symptoms (5 items) } 1) to 4) added together to generate a total difficulties score (based on 20 items)
2. conduct problems (5 items)
3. hyperactivity/inattention (5 items)
4. peer relationship problems (5 items)
5. prosocial behaviour (5 items)
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Timepoint [20]
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At 6 years of age
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Secondary outcome [21]
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Quality of life at 6 years of age
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Assessment method [21]
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Quality of life (QL) at 6 years of age by Child Health Utility 9D (CHU9D, parent proxy version; PedsQL Parent Report for Young Children ages 5-7) The questionnaire has 9 questions with 5 response levels per question. The CHU9D allows the analyst to obtain quality adjusted life years (QALYs) directly for use in cost utility analysis.
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Timepoint [21]
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At 6 years of age
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Secondary outcome [22]
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Quality of life regarding Food Allergy at 6 years of age
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Assessment method [22]
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Quality of life (QL) at 6 years of age by Food Allergy Quality of Life Questionnaires-Parent Form (FAQLQ-PF) All items are scored on a 7-point Likert scale from 0 (not at all troubled) to 6 (extremely troubled) \[22\]. The total scores are divided by the number of items answered, giving a range of scores from 0 to 6, with higher values indicating a poorer quality of life
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Timepoint [22]
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At 6 years of age
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Secondary outcome [23]
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Cardiovascular health (vascular function) at 6 years of age
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Assessment method [23]
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Cardiovascular health at 6 years of age determined by assessing vascular function through a pulse doppler recording of the blood flow
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Timepoint [23]
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At 6 years of age
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Secondary outcome [24]
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Cardiovascular health (Carotid and aortic Intima-Media Thickness) at 6 years of age
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Assessment method [24]
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Cardiovascular health (Carotid and aortic Intima-Media Thickness) at 6 years of age by acquiring images with simultaneous ECG gating
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Timepoint [24]
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At 6 years of age
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Secondary outcome [25]
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Cardiovascular health (Blood pressure) at 6 years of age
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Assessment method [25]
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Cardiovascular health (Brachial and central blood pressure ) at 6 years of age will be measured using the SphygmoCor® XCEL system.
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Timepoint [25]
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At 6 years of age
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Secondary outcome [26]
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Cardiovascular health (Arterial stiffness) at 6 years of age
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Assessment method [26]
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Cardiovascular health (Arterial stiffness ) at 6 years of age will be assessed by central and peripheral pulse wave velocity (PWV) and pressure waveform analysis (PWA) using a cuff for the femoral artery and tonometer pressure sensor for the carotid artery.
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Timepoint [26]
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At 6 years of age
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Secondary outcome [27]
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Dental health at 6 years of age
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Assessment method [27]
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Dental health at 6 years of age: A registered oral health professional will examine the participant's mouth and teeth, checking for cavities/dental decay as well as developmental mark on the teeth. In addition, a 3D scan and/or photographs of the participant's teeth will be taken to document findings.
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Timepoint [27]
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At 6 years of age
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Secondary outcome [28]
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Hearing health at 6 years of age
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Assessment method [28]
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Hearing health at 6 years of age by using SHOEBOX® Audiometry Professional Edition to measure hearing threshold
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Timepoint [28]
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At 6 years of age
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Eligibility
Key inclusion criteria
Each participant must meet the following criteria to be included in this study:
* Healthy, term (born no earlier than 2 weeks before estimated date of delivery), predominantly breastfeeding infants aged 6 to 12 weeks (inclusive) who are expected to be predominantly breastfed for at least 6-months. This will be determined by answering yes/no to question 'do you intend/wish to breastfeed until your infant is at least 6 months of age.' Up to one bottle (approx. 120mL) of formula per 24 hours at the time of screening is acceptable, as this will contain <100 IU vitamin D.
* Has a parent/legally acceptable representative (LAR) capable of understanding the informed consent document and providing consent on the subject's behalf,
* The parent must expect to be able to complete 4 online questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing (+/- food challenge) at The Royal Children's Hospital at 12 months of age.
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Minimum age
6
Weeks
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Maximum age
12
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
* Infants who are currently receiving vitamin D supplementation
* Infants on medication that interferes with vitamin D metabolism
* Poor health due to a current or past significant disease state or congenital abnormality.
* Prematurity <37 weeks/low birth weight <2500 g/Small for gestational age (SGA)
* Unable to provide consent without the aid of an interpreter.
* Women at high risk of vitamin D deficiency with infants on vitamin D supplementation.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
2739
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Murdoch Childrens Research Institute - Melbourne
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.
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Trial website
https://clinicaltrials.gov/study/NCT02112734
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Trial related presentations / publications
Allen KJ, Koplin JJ, Ponsonby AL, Gurrin LC, Wake M, Vuillermin P, Martin P, Matheson M, Lowe A, Robinson M, Tey D, Osborne NJ, Dang T, Tina Tan HT, Thiele L, Anderson D, Czech H, Sanjeevan J, Zurzolo G, Dwyer T, Tang ML, Hill D, Dharmage SC. Vitamin D insufficiency is associated with challenge-proven food allergy in infants. J Allergy Clin Immunol. 2013 Apr;131(4):1109-16, 1116.e1-6. doi: 10.1016/j.jaci.2013.01.017. Epub 2013 Feb 27. Allen KJ, Panjari M, Koplin JJ, Ponsonby AL, Vuillermin P, Gurrin LC, Greaves R, Carvalho N, Dalziel K, Tang ML, Lee KJ, Wake M, Curtis N, Dharmage SC. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health. BMJ Open. 2015 Dec 16;5(12):e009377. doi: 10.1136/bmjopen-2015-009377.
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Public notes
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Contacts
Principal investigator
Name
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Kirsten Perrett, MD PhD
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Address
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Murdoch Children's Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02112734
Download to PDF