Piloting a Dietary Vitamin E Intervention During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin E enhanced diet

Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week

Group Type EXPERIMENTAL

Vitamin E enhanced soup

Intervention Type DIETARY_SUPPLEMENT

vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients

Non-enhanced dietary intervention

Range of three similar looking and tasting soups (400g/tin) with naturally low (\<3mg) vitamin E content. Three portions per week

Group Type PLACEBO_COMPARATOR

Non-enhanced soups

Intervention Type DIETARY_SUPPLEMENT

Similar looking and tasting soups with low vitamin E content by virtue of food ingredients

Interventions

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Vitamin E enhanced soup

vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients

Intervention Type DIETARY_SUPPLEMENT

Non-enhanced soups

Similar looking and tasting soups with low vitamin E content by virtue of food ingredients

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No