The effects of prenatal vitamin D supplementation on child health

ISRCTN	ISRCTN68645785
DOI	https://doi.org/10.1186/ISRCTN68645785
Protocol serial number	8325
Sponsor	Imperial College London (UK)
Funder	Asthma UK (UK)

Submission date: 24/06/2010
Registration date: 24/06/2010
Last edited: 11/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Goldring
Scientific

Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom

Email	sgoldring@nhs.net

Study information

Primary study design	Interventional
Study design	Single-centre randomised interventional prevention trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of prenatal vitamin D supplementation on respiratory and allergic phenotypes and bone density in the first three years of life
Study objectives	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(s)	St Marys Hospital REC, 11/03/2010, ref: 10/H0712/13
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Percentage (%) of children with any wheezing episode in the first 3 years of life, measured at 36 - 48 months
Key secondary outcome measure(s)	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
Completion date	31/05/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Sex	All
Target sample size at registration	180
Key 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.
Key exclusion criteria	Severe congenital or developmental abnormalities likely to significantly affect respiratory health or lung function, e.g., congenital thoracic dystrophy.
Date of first enrolment	01/03/2010
Date of final enrolment	31/05/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Wright-Fleming Institute

London
W2 1PG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/06/2013		Yes	No
Results article	results	23/12/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/07/2016: Publication reference added.