Clinical trial NCT01661530: Piloting a Dietary Vitamin E Intervention During Pregnancy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
pregnancy
diet
vitamin E
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 59
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
timeFrame: 1 year
Secondary outcomes:
measure: Dietary vitamin E intake during pregnancy.
timeFrame: 1 year
measure: Lung function of new born infants.
timeFrame: 1 year
Other outcomes:
measure: Biomarker of dietary compliance
timeFrame: 1 year
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Maternity Hospital
Study officials:
affiliation: University of Aberdeen
name: Graham Devereux, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Litonjua 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.