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Piloting a Dietary Vitamin E Intervention During Pregnancy

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ClinicalTrials.gov Identifier: NCT01661530
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

August 7, 2012
August 9, 2012
January 14, 2014
December 2012
June 2013   (Final data collection date for primary outcome measure)
Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01661530 on ClinicalTrials.gov Archive Site
  • Dietary vitamin E intake during pregnancy. [ Time Frame: 1 year ]
  • Lung function of new born infants. [ Time Frame: 1 year ]
Same as current
Biomarker of dietary compliance [ Time Frame: 1 year ]
Same as current
 
Piloting a Dietary Vitamin E Intervention During Pregnancy
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.

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Asthma
  • 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
  • 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
    Intervention: Dietary Supplement: Vitamin E enhanced soup
  • 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
    Intervention: Dietary Supplement: Non-enhanced soups

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
50
January 2014
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
16 Years to 50 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01661530
2/0036/12
12/NS/0053 ( Other Identifier: North of Scotland Research Ethics Service )
Yes
Not Provided
Not Provided
University of Aberdeen
University of Aberdeen
Not Provided
Principal Investigator: Graham Devereux, MD University of Aberdeen
University of Aberdeen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP