Asthma
Conditions
Keywords
asthma, pregnancy, diet, vitamin E
Brief summary
In the last forty years the prevalence of asthma has increased in westernised countries. We have hypothesised that this increase may be a consequence of changing diet. Several birth cohort studies have now reported an association between reduced maternal vitamin E intake during pregnancy and childhood asthma. However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy reduces the risk of childhood asthma. We are planning a large placebo controlled trial in pregnant women, to investigate whether optimisation of dietary vitamin E intake to the recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary intervention using vitamin E in its natural form of food is more likely to be successful and acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women can optimise their vitamin E intake using a personalised dietary plan with the help of a dietitian however this intervention was complex and could not be translated into everyday use. With commercial support we have developed a range of soups containing foods naturally rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of similar tasting and looking placebo soups has also been developed. In this study we will pilot a randomised controlled trial of the active and placebo soups to ascertain whether pregnant women are willing and able to optimise their vitamin E intake during pregnancy using the soups in order to reduce the risk of their child developing asthma. optimising maternal vitamin E intake during pregnancy.
Interventions
DIETARY_SUPPLEMENTVitamin E enhanced soup
vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
DIETARY_SUPPLEMENTNon-enhanced soups
Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
Sponsors
University of Aberdeen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 10-12 weeks pregnant. * Routine low risk antenatal care. * A personal or partner history of asthma at anytime. * Able and willing to give informed consent to participate * Able and willing to participate in the study procedures
Exclusion criteria
* Use of vitamin E supplements. * A history of diabetes, coagulopathies or use of anticoagulants, use of clopidogrel, cholestyramine, cyclosporin A, gemfibrozil, isoniazid, orlistat, anticonvulsants. * Any other significant disease or disorder which, in the opinion of the investigator, either puts the woman at risk because of participating in the study or may influence the results of the study, or the woman's ability to participate in the study. * Participating in another clinical study * Previous allocation of randomisation code in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Dietary vitamin E intake during pregnancy. | 1 year |
| Lung function of new born infants. | 1 year |
Other
| Measure | Time frame |
|---|---|
| Biomarker of dietary compliance | 1 year |
Countries
United Kingdom
Outcome results
None listed