Condition category
Respiratory
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Goldring

ORCID ID

Contact details

Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom
-
sgoldring@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8325

Study information

Scientific title

Effects of prenatal vitamin D supplementation on respiratory and allergic phenotypes and bone density in the first three years of life

Acronym

Study hypothesis

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.

Ethics approval

St Marys Hospital REC, 11/03/2010, ref: 10/H0712/13

Study design

Single-centre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics

Intervention

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

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D supplementation

Primary outcome measures

Percentage (%) of children with any wheezing episode in the first 3 years of life, measured at 36 - 48 months

Secondary outcome measures

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

Overall trial start date

01/03/2010

Overall trial end date

31/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned sample size: 180; UK sample size: 180

Participant exclusion criteria

Severe congenital or developmental abnormalities likely to significantly affect respiratory health or lung function, e.g., congenital thoracic dystrophy.

Recruitment start date

01/03/2010

Recruitment end date

31/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wright-Fleming Institute
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

South Kensington Campus (Main Campus)
Imperial College
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Charity

Funder name

Asthma UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23826104
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26698303

Publication citations

  1. Results

    Goldring ST, Griffiths CJ, Martineau AR, Robinson S, Yu C, Poulton S, Kirkby JC, Stocks J, Hooper R, Shaheen SO, Warner JO, Boyle RJ, Prenatal vitamin d supplementation and child respiratory health: a randomised controlled trial., PLoS ONE, 2013, 8, 6, e66627, doi: 10.1371/journal.pone.0066627.

  2. Results

    Griffiths M, Goldring S, Griffiths C, Shaheen SO, Martineau A, Cross L, Robinson S, Warner JO, Devine A, Boyle RJ, Effects of Pre-Natal Vitamin D Supplementation with Partial Correction of Vitamin D Deficiency on Early Life Healthcare Utilisation: A Randomised Controlled Trial, PLoS One, 2015 , 10, 12, e0145303, doi: 10.1371/journal.pone.0145303.

Additional files

Editorial Notes

11/07/2016: Publication reference added.