search
Back to results

Piloting a Dietary Vitamin E Intervention During Pregnancy

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Vitamin E enhanced soup
Non-enhanced soups
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, pregnancy, diet, vitamin E

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Aberdeen Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin E enhanced diet

Non-enhanced dietary intervention

Arm Description

Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week

Range of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content. Three portions per week

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dietary vitamin E intake during pregnancy.
Lung function of new born infants.

Full Information

First Posted
August 7, 2012
Last Updated
January 13, 2014
Sponsor
University of Aberdeen
search

1. Study Identification

Unique Protocol Identification Number
NCT01661530
Brief Title
Piloting a Dietary Vitamin E Intervention During Pregnancy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, pregnancy, diet, vitamin E

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin E enhanced diet
Arm Type
Experimental
Arm Description
Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week
Arm Title
Non-enhanced dietary intervention
Arm Type
Placebo Comparator
Arm Description
Range of three similar looking and tasting soups (400g/tin) with naturally low (<3mg) vitamin E content. Three portions per week
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E enhanced soup
Intervention Description
vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
Intervention Type
Dietary Supplement
Intervention Name(s)
Non-enhanced soups
Intervention Description
Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
Primary Outcome Measure Information:
Title
Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Dietary vitamin E intake during pregnancy.
Time Frame
1 year
Title
Lung function of new born infants.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Biomarker of dietary compliance
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Devereux, MD
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aberdeen Maternity Hospital
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16763215
Citation
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.
Results Reference
background
PubMed Identifier
17023719
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. doi: 10.1093/ajcn/84.4.903.
Results Reference
background

Learn more about this trial

Piloting a Dietary Vitamin E Intervention During Pregnancy

We'll reach out to this number within 24 hrs