Piloting a Dietary Vitamin E Intervention During Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01661530
First received: August 7, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Asthma
Dietary Supplement: Vitamin E enhanced soup
Dietary Supplement: Non-enhanced soups

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

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary vitamin E intake during pregnancy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Lung function of new born infants. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Biomarker of dietary compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: December 2012
Study Completion Date: January 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin E enhanced diet
Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week
Dietary Supplement: Vitamin E enhanced soup
vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
Placebo Comparator: Non-enhanced dietary intervention
Range of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content. Three portions per week
Dietary Supplement: Non-enhanced soups
Similar looking and tasting soups with low vitamin E content by virtue of food ingredients

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01661530

Locations
United Kingdom
Aberdeen Maternity Hospital
Aberdeen, United Kingdom, AB25 2ZN
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Graham Devereux, MD University of Aberdeen
  More Information

Publications:
Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01661530     History of Changes
Other Study ID Numbers: 2/0036/12, 12/NS/0053
Study First Received: August 7, 2012
Last Updated: January 13, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
asthma
pregnancy
diet
vitamin E

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014