Piloting a Dietary Vitamin E Intervention During Pregnancy

University of Aberdeen

Status

Completed

Conditions

Asthma

Treatments

Dietary Supplement: Vitamin E enhanced soup

Dietary Supplement: Non-enhanced soups

Study type

Interventional

Funder types

Other

Identifiers

NCT01661530

2/0036/12

12/NS/0053 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

Female

Ages

16 to 50 years old

Volunteers

No Healthy Volunteers

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.