xml: <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/NCT06038344</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00111071</org_study_id>
      <nct_id>NCT06038344</nct_id>
    </id_info>
    <brief_title>Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease</brief_title>
    <official_title>Evaluation of the Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Newly Diagnosed Children and Youth With Celiac Disease in the Clinical Setting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alberta</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Alberta Health services</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Alberta</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Celiac disease (CD) is an autoimmune gastrointestinal disease that is caused by intolerance&#xD;
        to gluten in the diet. The mainstay of treatment is a gluten-free diet (GFD). Children with&#xD;
        CD on the GFD often have low micronutrient intakes (e.g. folate, iron) and high intakes of&#xD;
        sugar and fat. Current Canadian nutrition guideline does not address these nutritional&#xD;
        limitations. The investigation team developed a novel GF-food guide (GFFG). This randomized&#xD;
        clinical trial aims to evaluate the impact of GFFG on diet quality and adherence to the GFD&#xD;
        in newly diagnosed children and youth with celiac disease in the clinical setting. The&#xD;
        investigators will compare dietary counselling using the GFFG versus the standard of care in&#xD;
        children newly diagnosed with CD and their parents to see if participant care outcomes (diet&#xD;
        quality, nutrition literacy, adherence to the GFD) improved over six months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The only treatment for celiac disease (CD) is the gluten-free (GF) diet which&#xD;
        affects every 1 in 100 individuals. Non-adherence to the diet can lead to intestinal damage&#xD;
        and nutrient malabsorption, which can negatively impact a critical period of growth and&#xD;
        development in children. Despite adherence, the GF diet does not guarantee nutritional&#xD;
        adequacy in children and can lead to obesity and chronic disease. A number of studies confirm&#xD;
        that children and adults on GFDs often face several nutritional challenges, including low&#xD;
        intakes of fibre, vitamin D, zinc, magnesium and high intakes of simple sugars and saturated&#xD;
        fats associated with poor diet quality. Prepackaged GF foods are often high in simple sugars&#xD;
        and saturated fat while being low in fibre, which are all known risk factors for the&#xD;
        development of chronic disease in the adult population. While parents and newly diagnosed&#xD;
        children with CD show significant improvements in knowledge about the GF diet after receiving&#xD;
        standard-of-care education from healthcare practitioners at the time of diagnosis, some&#xD;
        children with CD continue to experience significant challenges with reduced diet quality and&#xD;
        nutritional inadequacy while on the GF diet, even after dietary education. Currently, there&#xD;
        are no existing nutrition guidelines that are focused on the GFD. To address this issue, the&#xD;
        investigation team recently developed a gluten-free food guide (GFFG). The GFFG consists of&#xD;
        overall diet recommendations with a layout that mirrors the new Canada's Food Guide,&#xD;
        associated teaching materials that address concepts related to nutrition literacy and&#xD;
        knowledge as identified in the pre-guide stakeholder engagement with health care providers&#xD;
        (RD, RN, MD) and families with children with CD (Mager et al., Br J Nutr 2022). Focus groups&#xD;
        and online surveys were conducted for feasibility analysis with end-stakeholders (health&#xD;
        professionals, parents/caregivers of children with CD, and adolescents with CD) to enable a&#xD;
        comprehensive evaluation of the feasibility of the food guide in terms of content and layout&#xD;
        (Mager et al., Br J Nutr 2022).&#xD;
  &#xD;
        Study Objective: The study purpose is to compare the impact of dietary counselling using the&#xD;
        GFFG versus standard of care (SOC) in children/adolescents and their parent/caregiver newly&#xD;
        diagnosed with CD on participant care outcomes (diet quality, nutrition literacy, adherence&#xD;
        to the GFD) over six months.&#xD;
  &#xD;
        Hypothesis: The GFFG will increase diet quality and parental food literacy and improve&#xD;
        adherence to the GFD in newly diagnosed children with CD and their parents over six months.&#xD;
  &#xD;
        Sample size: Forty families (20/group) are proposed to enroll in this study. This sample size&#xD;
        was based on a convenient sample.&#xD;
  &#xD;
        Data Analysis: Data will be expressed as mean (± SD) or median (interquartile range) for&#xD;
        parametric and non-parametric variables, respectively (tested by the Shapiro-Wilk test).&#xD;
        T-tests (parametric) or Mann Whitney (non-parametric) tests to compare household&#xD;
        characteristics (sociodemographic), adherence to the GFD, and DQ between SOC vs SOC+GFFG.&#xD;
        Pearson and/or Spearman correlations will be conducted to assess the associations between&#xD;
        child DQ and parental nutrition literacy, GFD adherence and household sociodemographics.&#xD;
        Chi-square tests will be used to determine significant differences between categorical&#xD;
        variables. P value &lt; 0.05 adjusted for multiple comparisons will determine statistical&#xD;
        significance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 22, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dietary quality</measure>
      <time_frame>Baseline</time_frame>
      <description>Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at study entry. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dietary quality</measure>
      <time_frame>6 months</time_frame>
      <description>Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at 6 months. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-reported adherence to the gluten-free diet.</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment of child/adolescent adherence to the GFD will be evaluated by a self-reported questionnaire (Kindl Test ®) at baseline. This is a questionnaire that consists of 10 questions related to dietary adherence and quality of life. Max score is 10. Minimum score is 0. Higher scores indicative of lower adherence and quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported adherence to the gluten-free diet</measure>
      <time_frame>6 months</time_frame>
      <description>Assessment of child/adolescent adherence to the GFD will be evaluated by a self-reported questionnaire (Kindl Test ®) at 6 months. This is a questionnaire that consists of 10 questions related to dietary adherence and quality of life. Max score is 10. Minimum score is 0. Higher scores indicative of lower adherence and quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gluten intake</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment of changes in child/adolescent gluten intake will be calculated from a 3-day food record using the gluten-calculation equation ((grain weight (in gms) *20)/1000) at study entry. Gluten Values less than 10 mg/d in the diet considered low gluten intake associated with adherence to the gluten free diet.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gluten intake</measure>
      <time_frame>6 months</time_frame>
      <description>Assessment of changes in child/adolescent gluten intake will be calculated from a 3-day food record using the gluten-calculation equation ((grain weight (in gms) *20)/1000)at 6 months. Gluten Values less than 10 mg/d in the diet considered low gluten intake associated with adherence to the gluten free diet.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Nutrition Literacy</measure>
      <time_frame>Baseline</time_frame>
      <description>Parental nutrition literacy will be measured using the validated Nutrition Literacy Assessment Tool for Adults at study entry. The validated tool consists of 30 questions and scoring can range between 0-30. Excellent scores &gt; 24.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Nutrition Literacy</measure>
      <time_frame>6 months</time_frame>
      <description>Parental nutrition literacy will be measured using the validated Nutrition Literacy Assessment Tool for Adults at six months. The validated tool consists of 30 questions and scoring can range between 0-30. Excellent scores &gt; 24.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Celiac Disease in Children</condition>
    <condition>Gluten Enteropathy</condition>
    <condition>Diet; Deficiency</condition>
    <condition>Adherence, Treatment</condition>
    <arm_group>
      <arm_group_label>Standard of Care + Gluten-free food guide teaching</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>45-minute dietary counselling session using the novel gluten-free food guide conducted by a researcher over Zoom. This occurs after standard of care dietary education by an RD. The gluten free teaching session in the study protocol focuses on the GF plate model, the rationale for the GF plate model, and addressing the individual participants dietary needs based on a dietary intake assessment by a trained investigator using specific educational materials that are present in the guide.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>45-minute group session on the gluten-free diet conducted by registered dietitians over Zoom. The registered dietitian's dietary education included a virtual group class focusing on gluten literacy, meal planning, food label reading and dietary intake based on Canada's Food Guide to Healthy Eating (2019).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Gluten-free food guide teaching</intervention_name>
      <description>Teaching the gluten-free food guide will be done over Zoom within 1-2 weeks of the dietitian's standard of care teaching (group Zoom session). This teaching will take 30-45 minutes and will be conducted by a trained researcher. The investigators will use the gluten-free food guide as teaching materials with a focus on the GF plate model, the rationale for the GF plate model, nutritional consideration of gluten-free diet and content related to the additional 24 teaching materials (e.g. folate, fibre, eating out, school lunches etc.) contained within the guide. Individualized dietary suggestions based on participants' food records will also be provided.</description>
      <arm_group_label>Standard of Care + Gluten-free food guide teaching</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children and adolescents, male and female, 5-18 years of age and their parents.&#xD;
  &#xD;
            -  Clinically diagnosed celiac disease&#xD;
  &#xD;
            -  Diagnosis within 3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children, male and female, &lt;5 years of age&#xD;
  &#xD;
            -  Celiac disease diagnosis &gt;3 months&#xD;
  &#xD;
            -  Children/adolescents diagnosed with type 1 diabetes (T1D)&#xD;
  &#xD;
            -  Not clinically diagnosed with celiac disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Diana R Mager</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alberta</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Clinical Research Unit, University of Alberta</name>
        <address>
          <city>Edmonton</city>
          <state>Alberta</state>
          <zip>T6G 0K2</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Nutritional considerations of a paediatric gluten-free food guide for coeliac disease. Br J Nutr. 2022 Feb 14;127(3):421-430. doi: 10.1017/S0007114521000994. Epub 2021 Mar 22.</citation>
      <PMID>33745459</PMID>
    </reference>
    <reference>
      <citation>Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Evaluation of a paediatric gluten-free food guide by children and youth with coeliac disease, their parents and health care professionals. Br J Nutr. 2022 Jun 28;127(12):1784-1795. doi: 10.1017/S0007114521002774. Epub 2021 Jul 23.</citation>
      <PMID>34294170</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gluten-Free Food Guide</keyword>
    <keyword>Dietary Education</keyword>
    <keyword>Dietary Quality</keyword>
    <keyword>Celiac Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Celiac Disease</mesh_term>
      <mesh_term>Malnutrition</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will only be presented in aggregate form in peer review publications and/or conference proceedings.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038344
  org study id: Pro00111071
  nct id: NCT06038344
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Celiac disease (CD) is an autoimmune gastrointestinal disease that is caused by intolerance
        to gluten in the diet. The mainstay of treatment is a gluten-free diet (GFD). Children with
        CD on the GFD often have low micronutrient intakes (e.g. folate, iron) and high intakes of
        sugar and fat. Current Canadian nutrition guideline does not address these nutritional
        limitations. The investigation team developed a novel GF-food guide (GFFG). This randomized
        clinical trial aims to evaluate the impact of GFFG on diet quality and adherence to the GFD
        in newly diagnosed children and youth with celiac disease in the clinical setting. The
        investigators will compare dietary counselling using the GFFG versus the standard of care in
        children newly diagnosed with CD and their parents to see if participant care outcomes (diet
        quality, nutrition literacy, adherence to the GFD) improved over six months.
  Background: The only treatment for celiac disease (CD) is the gluten-free (GF) diet which
        affects every 1 in 100 individuals. Non-adherence to the diet can lead to intestinal damage
        and nutrient malabsorption, which can negatively impact a critical period of growth and
        development in children. Despite adherence, the GF diet does not guarantee nutritional
        adequacy in children and can lead to obesity and chronic disease. A number of studies confirm
        that children and adults on GFDs often face several nutritional challenges, including low
        intakes of fibre, vitamin D, zinc, magnesium and high intakes of simple sugars and saturated
        fats associated with poor diet quality. Prepackaged GF foods are often high in simple sugars
        and saturated fat while being low in fibre, which are all known risk factors for the
        development of chronic disease in the adult population. While parents and newly diagnosed
        children with CD show significant improvements in knowledge about the GF diet after receiving
        standard-of-care education from healthcare practitioners at the time of diagnosis, some
        children with CD continue to experience significant challenges with reduced diet quality and
        nutritional inadequacy while on the GF diet, even after dietary education. Currently, there
        are no existing nutrition guidelines that are focused on the GFD. To address this issue, the
        investigation team recently developed a gluten-free food guide (GFFG). The GFFG consists of
        overall diet recommendations with a layout that mirrors the new Canada's Food Guide,
        associated teaching materials that address concepts related to nutrition literacy and
        knowledge as identified in the pre-guide stakeholder engagement with health care providers
        (RD, RN, MD) and families with children with CD (Mager et al., Br J Nutr 2022). Focus groups
        and online surveys were conducted for feasibility analysis with end-stakeholders (health
        professionals, parents/caregivers of children with CD, and adolescents with CD) to enable a
        comprehensive evaluation of the feasibility of the food guide in terms of content and layout
        (Mager et al., Br J Nutr 2022).
  
        Study Objective: The study purpose is to compare the impact of dietary counselling using the
        GFFG versus standard of care (SOC) in children/adolescents and their parent/caregiver newly
        diagnosed with CD on participant care outcomes (diet quality, nutrition literacy, adherence
        to the GFD) over six months.
  
        Hypothesis: The GFFG will increase diet quality and parental food literacy and improve
        adherence to the GFD in newly diagnosed children with CD and their parents over six months.
  
        Sample size: Forty families (20/group) are proposed to enroll in this study. This sample size
        was based on a convenient sample.
  
        Data Analysis: Data will be expressed as mean (± SD) or median (interquartile range) for
        parametric and non-parametric variables, respectively (tested by the Shapiro-Wilk test).
        T-tests (parametric) or Mann Whitney (non-parametric) tests to compare household
        characteristics (sociodemographic), adherence to the GFD, and DQ between SOC vs SOC+GFFG.
        Pearson and/or Spearman correlations will be conducted to assess the associations between
        child DQ and parental nutrition literacy, GFD adherence and household sociodemographics.
        Chi-square tests will be used to determine significant differences between categorical
        variables. P value < 0.05 adjusted for multiple comparisons will determine statistical
        significance.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Dietary quality
  time frame: Baseline
  description: Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at study entry. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.
  measure: Dietary quality
  time frame: 6 months
  description: Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at 6 months. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.
  measure: Self-reported adherence to the gluten-free diet.
  time frame: Baseline
  description: Assessment of child/adolescent adherence to the GFD will be evaluated by a self-reported questionnaire (Kindl Test ®) at baseline. This is a questionnaire that consists of 10 questions related to dietary adherence and quality of life. Max score is 10. Minimum score is 0. Higher scores indicative of lower adherence and quality of life.
  measure: Self-reported adherence to the gluten-free diet
  time frame: 6 months
  description: Assessment of child/adolescent adherence to the GFD will be evaluated by a self-reported questionnaire (Kindl Test ®) at 6 months. This is a questionnaire that consists of 10 questions related to dietary adherence and quality of life. Max score is 10. Minimum score is 0. Higher scores indicative of lower adherence and quality of life.
  measure: Gluten intake
  time frame: Baseline
  description: Assessment of changes in child/adolescent gluten intake will be calculated from a 3-day food record using the gluten-calculation equation ((grain weight (in gms) *20)/1000) at study entry. Gluten Values less than 10 mg/d in the diet considered low gluten intake associated with adherence to the gluten free diet.
  measure: Gluten intake
  time frame: 6 months
  description: Assessment of changes in child/adolescent gluten intake will be calculated from a 3-day food record using the gluten-calculation equation ((grain weight (in gms) *20)/1000)at 6 months. Gluten Values less than 10 mg/d in the diet considered low gluten intake associated with adherence to the gluten free diet.
  measure: Parental Nutrition Literacy
  time frame: Baseline
  description: Parental nutrition literacy will be measured using the validated Nutrition Literacy Assessment Tool for Adults at study entry. The validated tool consists of 30 questions and scoring can range between 0-30. Excellent scores > 24.
  measure: Parental Nutrition Literacy
  time frame: 6 months
  description: Parental nutrition literacy will be measured using the validated Nutrition Literacy Assessment Tool for Adults at six months. The validated tool consists of 30 questions and scoring can range between 0-30. Excellent scores > 24.
  arm group label: Standard of Care + Gluten-free food guide teaching
  arm group type: Experimental
  description: 45-minute dietary counselling session using the novel gluten-free food guide conducted by a researcher over Zoom. This occurs after standard of care dietary education by an RD. The gluten free teaching session in the study protocol focuses on the GF plate model, the rationale for the GF plate model, and addressing the individual participants dietary needs based on a dietary intake assessment by a trained investigator using specific educational materials that are present in the guide.
  arm group label: Standard of Care
  arm group type: No Intervention
  description: 45-minute group session on the gluten-free diet conducted by registered dietitians over Zoom. The registered dietitian's dietary education included a virtual group class focusing on gluten literacy, meal planning, food label reading and dietary intake based on Canada's Food Guide to Healthy Eating (2019).
  intervention type: Behavioral
  intervention name: Gluten-free food guide teaching
  description: Teaching the gluten-free food guide will be done over Zoom within 1-2 weeks of the dietitian's standard of care teaching (group Zoom session). This teaching will take 30-45 minutes and will be conducted by a trained researcher. The investigators will use the gluten-free food guide as teaching materials with a focus on the GF plate model, the rationale for the GF plate model, nutritional consideration of gluten-free diet and content related to the additional 24 teaching materials (e.g. folate, fibre, eating out, school lunches etc.) contained within the guide. Individualized dietary suggestions based on participants' food records will also be provided.
  arm group label: Standard of Care + Gluten-free food guide teaching
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Diana R Mager
  role: Principal Investigator
  affiliation: University of Alberta
  facility: 
  country: Canada
  citation: Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Nutritional considerations of a paediatric gluten-free food guide for coeliac disease. Br J Nutr. 2022 Feb 14;127(3):421-430. doi: 10.1017/S0007114521000994. Epub 2021 Mar 22.
  PMID: 33745459
  citation: Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Evaluation of a paediatric gluten-free food guide by children and youth with coeliac disease, their parents and health care professionals. Br J Nutr. 2022 Jun 28;127(12):1784-1795. doi: 10.1017/S0007114521002774. Epub 2021 Jul 23.
  PMID: 34294170
  responsible party type: Sponsor
  mesh term: Celiac Disease
  mesh term: Malnutrition
  sharing ipd: No
  ipd description: Data will only be presented in aggregate form in peer review publications and/or conference proceedings.