Piloting a Dietary Vitamin E Intervention During Pregnancy

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661530
• Other study ID #: 2/0036/12
• Secondary ID: 12/NS/0053
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: January 13, 2014
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• Vitamin E enhanced soup
vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
• Non-enhanced soups
Similar looking and tasting soups with low vitamin E content by virtue of food ingredients

Locations

Country	Name	City	State
United Kingdom	Aberdeen Maternity Hospital	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

References & 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. Epub 2006 Jun 8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarker of dietary compliance		1 year	No
Primary	Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.		1 year	No
Secondary	Dietary vitamin E intake during pregnancy.		1 year	No
Secondary	Lung function of new born infants.		1 year	No