The effects of prenatal vitamin D supplementation on child health
| ISRCTN | ISRCTN68645785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68645785 |
| Secondary identifying numbers | 8325 |
- 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
Scientific
Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom
| sgoldring@nhs.net |
Study information
| Study design | Single-centre randomised interventional prevention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2010 |
| Completion date | 31/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 180; UK sample size: 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
- England
- United Kingdom
Study participating centre
Wright-Fleming Institute
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
South Kensington Campus (Main Campus)
Imperial College
London
SW7 2AZ
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Asthma UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Asthma UK, Asthma + Lung UK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
Editorial Notes
11/07/2016: Publication reference added.
