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Piloting a Dietary Vitamin E Intervention During Pregnancy

NCT01661530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-01-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin E enhanced soup

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

DIETARY_SUPPLEMENT

Non-enhanced soups

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

Sponsors & Collaborators

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Graham Devereux, MD · University of Aberdeen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-06-30
Completion
2014-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01661530 on ClinicalTrials.gov