Completed

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.

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What is being tested

Vitamin E enhanced soup

+ Non-enhanced soups

Dietary Supplement
Who is being recruted

Bronchial Diseases+6

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 16 to 50 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorUniversity of Aberdeen
Last updated: January 14, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01661530
Principal SponsorUniversity of Aberdeen
Last updated: January 14, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 16 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract DiseasesAsthma

Criteria

5 inclusion criteria required to participate
10-12 weeks pregnant

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

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5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Aberdeen Maternity Hospital

Aberdeen, United KingdomOpen Aberdeen Maternity Hospital in Google Maps
CompletedOne Study Center