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Piloting a Dietary Vitamin E Intervention During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661530
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
University of Aberdeen

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Dietary Supplement: Vitamin E enhanced soup Dietary Supplement: Non-enhanced soups Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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.
Study Start Date : December 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: 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
Dietary Supplement: Vitamin E enhanced soup
vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients

Placebo Comparator: 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
Dietary Supplement: Non-enhanced soups
Similar looking and tasting soups with low vitamin E content by virtue of food ingredients

Primary Outcome Measures :
  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 Outcome Measures :
  1. Dietary vitamin E intake during pregnancy. [ Time Frame: 1 year ]
  2. Lung function of new born infants. [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Biomarker of dietary compliance [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01661530

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United Kingdom
Aberdeen Maternity Hospital
Aberdeen, United Kingdom, AB25 2ZN
Sponsors and Collaborators
University of Aberdeen
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Principal Investigator: Graham Devereux, MD University of Aberdeen
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Responsible Party: University of Aberdeen Identifier: NCT01661530    
Other Study ID Numbers: 2/0036/12
12/NS/0053 ( Other Identifier: North of Scotland Research Ethics Service )
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by University of Aberdeen:
vitamin E
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents