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.
2 other identifiers
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 9, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJanuary 14, 2014
January 1, 2014
6 months
August 7, 2012
January 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
1 year
Secondary Outcomes (2)
Dietary vitamin E intake during pregnancy.
1 year
Lung function of new born infants.
1 year
Other Outcomes (1)
Biomarker of dietary compliance
1 year
Study Arms (2)
Vitamin E enhanced diet
EXPERIMENTALRange of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week
Non-enhanced dietary intervention
PLACEBO COMPARATORRange of three similar looking and tasting soups (400g/tin) with naturally low (\<3mg) vitamin E content. Three portions per week
Interventions
vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aberdeen Maternity Hospital
Aberdeen, Aberdeen, AB25 2ZN, United Kingdom
Related Publications (2)
Devereux G, Turner SW, Craig LC, McNeill G, Martindale S, Harbour PJ, Helms PJ, Seaton A. Low maternal vitamin E intake during pregnancy is associated with asthma in 5-year-old children. Am J Respir Crit Care Med. 2006 Sep 1;174(5):499-507. doi: 10.1164/rccm.200512-1946OC. Epub 2006 Jun 8.
PMID: 16763215BACKGROUNDLitonjua AA, Rifas-Shiman SL, Ly NP, Tantisira KG, Rich-Edwards JW, Camargo CA Jr, Weiss ST, Gillman MW, Gold DR. Maternal antioxidant intake in pregnancy and wheezing illnesses in children at 2 y of age. Am J Clin Nutr. 2006 Oct;84(4):903-11. doi: 10.1093/ajcn/84.4.903.
PMID: 17023719BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Graham Devereux, MD
University of Aberdeen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 9, 2012
Study Start
December 1, 2012
Primary Completion
June 1, 2013
Study Completion
January 1, 2014
Last Updated
January 14, 2014
Record last verified: 2014-01