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临床试验/NCT01661530
NCT01661530已完成不适用

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.

University of Aberdeen2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.

时间窗: 1 year

次要结局

  • Dietary vitamin E intake during pregnancy.(1 year)
  • Lung function of new born infants.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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