Skip to main content
OpenTrials
Completed

NCT Number: NCT01661530

Piloting a Dietary Vitamin E Intervention During Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aberdeen Maternity Hospital

Aberdeen, AB25 2ZN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin E enhanced soup

Dietary Supplement

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

Non-enhanced soups

Dietary Supplement

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

Primary outcomes

  1. Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.

    Time frame: 1 year

Secondary outcomes

  1. Dietary vitamin E intake during pregnancy.

    Time frame: 1 year

  2. Lung function of new born infants.

    Time frame: 1 year

Other outcomes

  1. Biomarker of dietary compliance

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 9, 2012
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.