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ISRCTN
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ISRCTN68645785
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ClinicalTrials.gov identifier
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Public title
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The effects of prenatal vitamin D supplementation on child health
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Scientific title
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Effects of prenatal vitamin D supplementation on respiratory and allergic phenotypes and bone density in the first three years of life
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Acronym
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N/A
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Serial number at source
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8325
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Study hypothesis
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Asthma is the commonest chronic disease of childhood in the United Kingdom. In a recent study the prevalence of asthma in the UK was 20.9% in children aged 6 - 7 years, and 24.7% in young people aged 13 - 14 years old. Asthma is not curable once it has developed, and in most cases has its origins in early childhood. There is a justified focus on understanding the early life origins of asthma, with a view to developing primary prevention strategies.
This is a follow up study of a previously conducted randomised controlled trial (entitled 'Vitamin D deficiency and supplementation during pregnancy'). In that study, 180 mothers attending antenatal clinic at St Marys hospital were randomised at 27 weeks gestation to either no vitamin D (n = 60), 800 IU of vitamin D daily for the remainder of pregnancy (n = 60) or a single oral dose of 200,000 IU vitamin D at 27 weeks gestation.
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Lay summary
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Ethics approval
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St Marys Hospital REC approved on the 11th March 2010 (ref: 10/H0712/13)
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Study design
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Single centre randomised interventional prevention trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics
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Participants - inclusion criteria
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All of the offspring of the 180 mothers recruited in the Vitamin D deficiency and supplementation during pregnancy trial are eligible and are invited to participate in this follow up study when their children are 3 years of age.
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Participants - exclusion criteria
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Severe congenital or developmental abnormalities likely to significantly affect respiratory health or lung function, e.g., congenital thoracic dystrophy.
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Anticipated start date
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01/03/2010
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Anticipated end date
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31/05/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 180; UK sample size: 180
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Interventions
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1. Control group: women received no vitamin D supplementation (n = 60)
2. Daily Vitamin D: women received 800 IU of vitamin D (ergocalciferol) daily from 27 weeks gestation until delivery (n = 60)
3. Stat Vitamin D: women received a single stat dose of 200,000 IU vitamin D (calciferol) at 27 weeks gestation (n = 60)
Study entry: single randomisation only
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Primary outcome measure(s)
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Percentage (%) of children with any wheezing episode in the first 3 years of life, measured at 36 - 48 months
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Secondary outcome measure(s)
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All measured at 36 - 48 months:
1. % of children using inhaled bronchodilators in the last 12 months
2. % of children with doctor diagnosed rhinitis
3. % of children with any wheezing episode in the preceding 12 months
4. % of children with doctor diagnosed asthma
5. % of children with doctor diagnosed eczema
6. % of children with doctor diagnosed food allergy
7. % of children with positive skin prick test responses
8. 25-hydroxyvitamin D levels
9. Bronchodilator responsiveness
10. Exhaled nitric oxide level (in parts per billion)
11. Nasal secretions for inflammatory mediators
12. Pulmonary airflow resistance and reactance at a range of frequencies using impulse oscillometry
13. Total number of all wheezing episodes since birth
14. Total number of upper and lower respiratory tract infections since birth
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Sources of funding
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Asthma UK (UK)
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Trial website
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Publications
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Contact name
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Dr
Stephen
Goldring
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Address
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Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
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City/town
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London
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Zip/Postcode
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W2 1PG
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Country
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United Kingdom
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Email
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sgoldring@nhs.net
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Sponsor
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Imperial College London (UK)
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Address
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South Kensington Campus (Main Campus)
Imperial College
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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24/06/2010
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Last edited
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24/06/2010
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Date ISRCTN assigned
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24/06/2010
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