Asthma Clinical Trial
Official title:
A Double Blind Randomised Placebo Controlled Pilot Study of a Dietary Soup Intervention During Pregnancy to Optimise Dietary Vitamin E Intake in Relation to Childhood Asthma.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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