<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01661530</url>
  </required_header>
  <id_info>
    <org_study_id>2/0036/12</org_study_id>
    <secondary_id>12/NS/0053</secondary_id>
    <nct_id>NCT01661530</nct_id>
  </id_info>
  <brief_title>Piloting a Dietary Vitamin E Intervention During Pregnancy</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aberdeen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the last forty years the prevalence of asthma has increased in westernised countries. We&#xD;
      have hypothesised that this increase may be a consequence of changing diet. Several birth&#xD;
      cohort studies have now reported an association between reduced maternal vitamin E intake&#xD;
      during pregnancy and childhood asthma.&#xD;
&#xD;
      However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy&#xD;
      reduces the risk of childhood asthma. We are planning a large placebo controlled trial in&#xD;
      pregnant women, to investigate whether optimisation of dietary vitamin E intake to the&#xD;
      recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary&#xD;
      intervention using vitamin E in its natural form of food is more likely to be successful and&#xD;
      acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women&#xD;
      can optimise their vitamin E intake using a personalised dietary plan with the help of a&#xD;
      dietitian however this intervention was complex and could not be translated into everyday&#xD;
      use. With commercial support we have developed a range of soups containing foods naturally&#xD;
      rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of&#xD;
      similar tasting and looking placebo soups has also been developed. In this study we will&#xD;
      pilot a randomised controlled trial of the active and placebo soups to ascertain whether&#xD;
      pregnant women are willing and able to optimise their vitamin E intake during pregnancy using&#xD;
      the soups in order to reduce the risk of their child developing asthma. optimising maternal&#xD;
      vitamin E intake during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary vitamin E intake during pregnancy.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function of new born infants.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarker of dietary compliance</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Vitamin E enhanced diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-enhanced dietary intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Range of three similar looking and tasting soups (400g/tin) with naturally low (&lt;3mg) vitamin E content. Three portions per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin E enhanced soup</intervention_name>
    <description>vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients</description>
    <arm_group_label>Vitamin E enhanced diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Non-enhanced soups</intervention_name>
    <description>Similar looking and tasting soups with low vitamin E content by virtue of food ingredients</description>
    <arm_group_label>Non-enhanced dietary intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10-12 weeks pregnant.&#xD;
&#xD;
          -  Routine low risk antenatal care.&#xD;
&#xD;
          -  A personal or partner history of asthma at anytime.&#xD;
&#xD;
          -  Able and willing to give informed consent to participate&#xD;
&#xD;
          -  Able and willing to participate in the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of vitamin E supplements.&#xD;
&#xD;
          -  A history of diabetes, coagulopathies or use of anticoagulants, use of clopidogrel,&#xD;
             cholestyramine, cyclosporin A, gemfibrozil, isoniazid, orlistat, anticonvulsants.&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the investigator,&#xD;
             either puts the woman at risk because of participating in the study or may influence&#xD;
             the results of the study, or the woman's ability to participate in the study.&#xD;
&#xD;
          -  Participating in another clinical study&#xD;
&#xD;
          -  Previous allocation of randomisation code in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graham Devereux, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aberdeen Maternity Hospital</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>16763215</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17023719</PMID>
  </reference>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>January 13, 2014</last_update_submitted>
  <last_update_submitted_qc>January 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>pregnancy</keyword>
  <keyword>diet</keyword>
  <keyword>vitamin E</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin E</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01661530
org study id: 2/0036/12
secondary id: 12/NS/0053
nct id: NCT01661530
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Participation of pregnant women in a randomised trial of enhanced and placebo soups from 12 weeks gestation until delivery.
time frame: 1 year
measure: Dietary vitamin E intake during pregnancy.
time frame: 1 year
measure: Lung function of new born infants.
time frame: 1 year
measure: Biomarker of dietary compliance
time frame: 1 year
arm group label: Vitamin E enhanced diet
arm group type: Experimental
description: Range of three vitamin E enhanced soups (400g/tin) containing 18-20mg vitamin in natural food form. Three portions per week
arm group label: Non-enhanced dietary intervention
arm group type: Placebo Comparator
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: Vitamin E enhanced soup
description: vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
arm group label: Vitamin E enhanced diet
intervention type: Dietary Supplement
intervention name: Non-enhanced soups
description: Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
arm group label: Non-enhanced dietary intervention
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 50 Years
healthy volunteers: No
last name: Graham Devereux, MD
role: Principal Investigator
affiliation: University of Aberdeen
facility: 
country: United Kingdom
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.
PMID: 16763215
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.
PMID: 17023719
responsible party type: Sponsor
mesh term: Asthma
mesh term: Vitamin E