Development and piloting of a food-based intervention to increase vitamin E intake in pregnant women in a randomised controlled trial

Julia Clark, Nikki Holgan, Leone Craig, Heather Morgan, Peter Danielian, Graham Devereux

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Abstract

Low maternal vitamin E intake during pregnancy is associated with childhood asthma and a trial is required to test whether increasing maternal vitamin E intake reduces childhood asthma. This study investigated whether such a trial is possible using food to increase vitamin E intake. Three soup varieties with enhanced vitamin E content (16–19 mg/can) from food ingredients were developed. Near identical retail versions (vitamin E 1–4 mg/can) acted as placebo. In a pilot double-blind randomized controlled trial, pregnant women were randomized 1:1 to enhanced or placebo soups (three tins/week) from 12 weeks gestation to delivery. Vitamin E intake was quantified at 12, 20, and 34 weeks gestation. Qualitative interviews were conducted. 59 women were randomized (29 enhanced, 30 placebo), 28 completed the trial, (15 enhanced, 13 placebo). In women completing the trial, vitamin E intake of the placebo group remained unchanged; 7.09 mg/d (95% CI 5.41–8.77) at 12 weeks, 6.41 mg/d (5.07–7.75) at 20 weeks, and 6.67 mg/d (5.38–7.96) at 34 weeks gestation; vitamin E intake of the enhanced group increased from 6.50 mg/d (5.21–7.79) at 12 weeks to 14.9 mg/d (13.3–16.4) at 20 weeks and 15.2 mg/d (12.9–17.5) at 34 weeks, P < 0.001. Qualitative interviewing provided clear guidance on improving adherence. Although 31 women withdrew at median 19 weeks gestation (interquartile range 16–25), the intervention was consumed by women for 80% of weeks between 12 and 34 weeks gestation and for 63% of weeks between 12 weeks gestation and delivery. In a pilot double-blind randomized controlled trial (RCT) it is possible to increase maternal vitamin E intake using food ingredients, a further food product is required to improve adherence.
Original languageEnglish
Pages (from-to)848-851
Number of pages4
JournalFood Science and Nutrition
Volume4
Issue number6
Early online date2 Mar 2016
DOIs
Publication statusPublished - 2 Nov 2016

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pregnant women
Vitamin E
vitamin E
Pregnant Women
Randomized Controlled Trials
Food
pregnancy
placebos
Pregnancy
Placebos
soups
Mothers
asthma
cans
childhood
ingredients
Asthma
tin
Tin
food intake

Keywords

  • asthma
  • food
  • pilot randomized controlled trial
  • pregnancy
  • Vitamin E

Cite this

Development and piloting of a food-based intervention to increase vitamin E intake in pregnant women in a randomised controlled trial. / Clark, Julia; Holgan, Nikki; Craig, Leone; Morgan, Heather; Danielian, Peter; Devereux, Graham.

In: Food Science and Nutrition, Vol. 4, No. 6, 02.11.2016, p. 848-851.

Research output: Contribution to journalArticle

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abstract = "Low maternal vitamin E intake during pregnancy is associated with childhood asthma and a trial is required to test whether increasing maternal vitamin E intake reduces childhood asthma. This study investigated whether such a trial is possible using food to increase vitamin E intake. Three soup varieties with enhanced vitamin E content (16–19 mg/can) from food ingredients were developed. Near identical retail versions (vitamin E 1–4 mg/can) acted as placebo. In a pilot double-blind randomized controlled trial, pregnant women were randomized 1:1 to enhanced or placebo soups (three tins/week) from 12 weeks gestation to delivery. Vitamin E intake was quantified at 12, 20, and 34 weeks gestation. Qualitative interviews were conducted. 59 women were randomized (29 enhanced, 30 placebo), 28 completed the trial, (15 enhanced, 13 placebo). In women completing the trial, vitamin E intake of the placebo group remained unchanged; 7.09 mg/d (95{\%} CI 5.41–8.77) at 12 weeks, 6.41 mg/d (5.07–7.75) at 20 weeks, and 6.67 mg/d (5.38–7.96) at 34 weeks gestation; vitamin E intake of the enhanced group increased from 6.50 mg/d (5.21–7.79) at 12 weeks to 14.9 mg/d (13.3–16.4) at 20 weeks and 15.2 mg/d (12.9–17.5) at 34 weeks, P < 0.001. Qualitative interviewing provided clear guidance on improving adherence. Although 31 women withdrew at median 19 weeks gestation (interquartile range 16–25), the intervention was consumed by women for 80{\%} of weeks between 12 and 34 weeks gestation and for 63{\%} of weeks between 12 weeks gestation and delivery. In a pilot double-blind randomized controlled trial (RCT) it is possible to increase maternal vitamin E intake using food ingredients, a further food product is required to improve adherence.",
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AB - Low maternal vitamin E intake during pregnancy is associated with childhood asthma and a trial is required to test whether increasing maternal vitamin E intake reduces childhood asthma. This study investigated whether such a trial is possible using food to increase vitamin E intake. Three soup varieties with enhanced vitamin E content (16–19 mg/can) from food ingredients were developed. Near identical retail versions (vitamin E 1–4 mg/can) acted as placebo. In a pilot double-blind randomized controlled trial, pregnant women were randomized 1:1 to enhanced or placebo soups (three tins/week) from 12 weeks gestation to delivery. Vitamin E intake was quantified at 12, 20, and 34 weeks gestation. Qualitative interviews were conducted. 59 women were randomized (29 enhanced, 30 placebo), 28 completed the trial, (15 enhanced, 13 placebo). In women completing the trial, vitamin E intake of the placebo group remained unchanged; 7.09 mg/d (95% CI 5.41–8.77) at 12 weeks, 6.41 mg/d (5.07–7.75) at 20 weeks, and 6.67 mg/d (5.38–7.96) at 34 weeks gestation; vitamin E intake of the enhanced group increased from 6.50 mg/d (5.21–7.79) at 12 weeks to 14.9 mg/d (13.3–16.4) at 20 weeks and 15.2 mg/d (12.9–17.5) at 34 weeks, P < 0.001. Qualitative interviewing provided clear guidance on improving adherence. Although 31 women withdrew at median 19 weeks gestation (interquartile range 16–25), the intervention was consumed by women for 80% of weeks between 12 and 34 weeks gestation and for 63% of weeks between 12 weeks gestation and delivery. In a pilot double-blind randomized controlled trial (RCT) it is possible to increase maternal vitamin E intake using food ingredients, a further food product is required to improve adherence.

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