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| ID | Type | Description | Link |
|---|---|---|---|
| 12/NS/0053 | Other Identifier | North of Scotland Research Ethics Service |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E enhanced diet | Experimental | Range 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 Comparator | Range of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content. Three portions per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E enhanced soup | Dietary Supplement | vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary vitamin E intake during pregnancy. | 1 year | |
| Lung function of new born infants. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker of dietary compliance | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham Devereux, MD | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Maternity Hospital | Aberdeen | Aberdeen | AB25 2ZN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16763215 | Background | 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. | |
| 17023719 | Background |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Non-enhanced soups | Dietary Supplement | Similar looking and tasting soups with low vitamin E content by virtue of food ingredients |
|
| 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |