Piloting a Dietary Vitamin E Intervention During Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Vitamin E enhanced soup
* Dietary Supplement: Non-enhanced soups


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E enhanced diet<br>Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week | Dietary Supplement: Vitamin E enhanced soup<br>* vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients<br>|
| Placebo Comparator: Non-enhanced dietary intervention<br>Range of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content. Three portions per week | Dietary Supplement: Non-enhanced soups<br>* Similar looking and tasting soups with low vitamin E content by virtue of food ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary vitamin E intake during pregnancy. |  | 1 year | 
| Lung function of new born infants. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, pregnancy, diet, vitamin E