<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/NCT03841188</url>
  </required_header>
  <id_info>
    <org_study_id>2011-0585</org_study_id>
    <nct_id>NCT03841188</nct_id>
  </id_info>
  <brief_title>Nutritional Interventional in Pediatric Patients With Osteogenesis Imperfecta</brief_title>
  <official_title>Calcium Intake Improvement After Nutritional Intervention in Pediatric Patients With Osteogenesis Imperfecta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      BACKGROUND: In several bone disorders, adequate calcium intake is a coadjuvant intervention&#xD;
      to regular treatment. Osteogenesis imperfecta (OI) is a collagen disorder with a range of&#xD;
      symptoms, ranging from fractures to minimum trauma, and is typically treated with&#xD;
      bisphosphonates. This study aims evaluate the impact of a nutritional intervention (NI) on&#xD;
      dietary calcium intake, bone mineral density (BMD)in pediatric patients with OI. METHODS:&#xD;
      Interventional cohort study was designed with a NI. Dietary calcium intake, anthropometry and&#xD;
      clinical feature was assessed at baseline including anthropometry, basal metabolic rate&#xD;
      (BMR), BMD, Food guidance form was developed and sent to patients by mail. After 12 months,&#xD;
      patients' clinical features were reassessed and compared with baseline data. RESULTS:&#xD;
      Fifty-two children and adolescents were enrolled. A significant increase in total calcium&#xD;
      intake (g), the percentage of adequate calcium intake (%), number of cups of milk ingested,&#xD;
      were observed after NI. Was detected a positive correlation between the variation of BMD and&#xD;
      milk consumption in patients treated with bisphosphonate. CONCLUSION: Was observed an&#xD;
      increase in calcium intake in patients with OI. This finding demonstrates the importance of&#xD;
      nutrition therapy as part of a multidisciplinary treatment approach for bone health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nutrition Intervention NI was performed at three nutritional visits (baseline, 6 and 12&#xD;
      months). Clinical features were evaluated at baseline, including anthropometric measurements,&#xD;
      basal metabolic rate (BMR), BMD An indirect calorimetry test was performed to estimate the&#xD;
      BMR of each participant. Dietary intake was assessed using daily food intake report completed&#xD;
      by participants on three non-consecutive days. The frequency of consumption and amount of&#xD;
      calcium intake were evaluated using a food frequency questionaire (FFQ) with emphasis on&#xD;
      foods rich in calcium. Based on these data, the nutritional needs for each subject were&#xD;
      calculated, and personalized food guidance (including recipes rich in calcium) was delivered&#xD;
      by mail.&#xD;
&#xD;
      In the second visit, at 6 months after baseline, adaptations were made to food guidance&#xD;
      according to the needs of each patient, doubts about feeding were clarified and the&#xD;
      importance of a diet rich in calcium was reinforced.&#xD;
&#xD;
      On the third visit, at 12 months after baseline, dietary calcium intake, anthropometric&#xD;
      measurements, , BMD were re-evaluated.&#xD;
&#xD;
      Calcium Intake Calcium intake was assessed using an FFQ adapted to calcium intake applied&#xD;
      before and after the NI. In the present study, the focus was on the consumption of foods high&#xD;
      in calcium, such as milk, yogurt, and cheese. To establish the percentage of the adequacy of&#xD;
      intake, the values obtained from the FFQ were compared with the Estimated Average Requirement&#xD;
      (EAD) and Recommended Dietary Allowances (RDA).&#xD;
&#xD;
      The FFQ for calcium intake was composed of milk (1 cup = 175 ml), 1 yogurt (120 ml), and&#xD;
      cheese (1 medium slice = 30 g). These foods were classified according to the consumer (as D,&#xD;
      daily; W, weekly, and M, monthly) and indicating the number of times (1 to 10) and the size&#xD;
      of the corresponding portion, if greater, equal or less than the given portion (according to&#xD;
      a poster with color photos to illustrate the portion size of each food source of calcium).&#xD;
&#xD;
      Consumption of glasses of milk and soda were also evaluated according to quantity and&#xD;
      frequency (For milk, 0 = does not consume, 1 = consume &lt; 1 cup per day, 2 = consume 1 to 2&#xD;
      cups/day, and 3 = consume 3 or more cups of milk/day; for soda, 1 = consume daily, 2 =&#xD;
      consume only on weekends or 2 times/week, 3 = consumes less than 1 day/week, and 4 = does not&#xD;
      consume).&#xD;
&#xD;
      Clinical Data Clinical data were obtained during the enrollment and included age, gender, OI&#xD;
      type, use of bisphosphonates, and calcium intake.&#xD;
&#xD;
      Anthropometric Data and Basal Metabolic Rate Anthropometric measurements (weight and height)&#xD;
      were measured and evaluated according to the z-score proposed by the World Health&#xD;
      Organization WHO. The length was measured in the supine position in children smaller than 1 m&#xD;
      and children could not remain in the standing position. Patients over 1.04 m and unable to&#xD;
      remain standing were measured in the supine position. BMI was calculated according to the&#xD;
      WHO. The BMR was evaluated through indirect calorimetry and the data was published&#xD;
      previously.&#xD;
&#xD;
      Bone Mineral Density BMD was determined before and after the intervention using Dual Energy&#xD;
      X-Ray Absorptiometry (DEXA) on a Lunar DXA (GE Healthcare, San Francisco, USA). Bone mineral&#xD;
      content (BMC) (g), lumbar spine BMD (L1-L4), and total body BMC (TB) were calculated and&#xD;
      expressed as z-scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2012</start_date>
  <completion_date type="Actual">February 10, 2014</completion_date>
  <primary_completion_date type="Actual">May 20, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Calcium intake</measure>
    <time_frame>12 months</time_frame>
    <description>Was assessed using an food frequency questionaire adapted to calcium intake</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Consumption of glasses of milk</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated according to quantity and frequency (For milk, 0 = does not consume, 1 = consume &lt; 1 cup per day, 2 = consume 1 to 2 cups/day, and 3 = consume 3 or more cups of milk/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>12 months</time_frame>
    <description>Calculation divides an children's weight in kilograms by their height in metres squared.Evaluated according to the z-score proposed by the WHO (2006, 2007)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>12 months</time_frame>
    <description>Bone mineral density was assessed thought Dual-energy X-ray absorptiometry</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Osteogenesis Imperfecta</condition>
  <arm_group>
    <arm_group_label>Nutritional Orientation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients received a nutritional orientation with emphasis in food rich in calcium</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional orientation</intervention_name>
    <description>Nutritional orientation with emphasis in rich calcium food</description>
    <arm_group_label>Nutritional Orientation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients from zero to 19 years of patients seen at hospital.&#xD;
&#xD;
          -  Diagnosed with osteogenesis imperfecta&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Diagnosed with bone disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elza D Mello, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-007</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteogenesis imperfecta</keyword>
  <keyword>Nutritional intervention</keyword>
  <keyword>calcium intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteogenesis Imperfecta</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03841188
org study id: 2011-0585
nct id: NCT03841188
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND: In several bone disorders, adequate calcium intake is a coadjuvant intervention
      to regular treatment. Osteogenesis imperfecta (OI) is a collagen disorder with a range of
      symptoms, ranging from fractures to minimum trauma, and is typically treated with
      bisphosphonates. This study aims evaluate the impact of a nutritional intervention (NI) on
      dietary calcium intake, bone mineral density (BMD)in pediatric patients with OI. METHODS:
      Interventional cohort study was designed with a NI. Dietary calcium intake, anthropometry and
      clinical feature was assessed at baseline including anthropometry, basal metabolic rate
      (BMR), BMD, Food guidance form was developed and sent to patients by mail. After 12 months,
      patients' clinical features were reassessed and compared with baseline data. RESULTS:
      Fifty-two children and adolescents were enrolled. A significant increase in total calcium
      intake (g), the percentage of adequate calcium intake (%), number of cups of milk ingested,
      were observed after NI. Was detected a positive correlation between the variation of BMD and
      milk consumption in patients treated with bisphosphonate. CONCLUSION: Was observed an
      increase in calcium intake in patients with OI. This finding demonstrates the importance of
      nutrition therapy as part of a multidisciplinary treatment approach for bone health.
Nutrition Intervention NI was performed at three nutritional visits (baseline, 6 and 12
      months). Clinical features were evaluated at baseline, including anthropometric measurements,
      basal metabolic rate (BMR), BMD An indirect calorimetry test was performed to estimate the
      BMR of each participant. Dietary intake was assessed using daily food intake report completed
      by participants on three non-consecutive days. The frequency of consumption and amount of
      calcium intake were evaluated using a food frequency questionaire (FFQ) with emphasis on
      foods rich in calcium. Based on these data, the nutritional needs for each subject were
      calculated, and personalized food guidance (including recipes rich in calcium) was delivered
      by mail.

      In the second visit, at 6 months after baseline, adaptations were made to food guidance
      according to the needs of each patient, doubts about feeding were clarified and the
      importance of a diet rich in calcium was reinforced.

      On the third visit, at 12 months after baseline, dietary calcium intake, anthropometric
      measurements, , BMD were re-evaluated.

      Calcium Intake Calcium intake was assessed using an FFQ adapted to calcium intake applied
      before and after the NI. In the present study, the focus was on the consumption of foods high
      in calcium, such as milk, yogurt, and cheese. To establish the percentage of the adequacy of
      intake, the values obtained from the FFQ were compared with the Estimated Average Requirement
      (EAD) and Recommended Dietary Allowances (RDA).

      The FFQ for calcium intake was composed of milk (1 cup = 175 ml), 1 yogurt (120 ml), and
      cheese (1 medium slice = 30 g). These foods were classified according to the consumer (as D,
      daily; W, weekly, and M, monthly) and indicating the number of times (1 to 10) and the size
      of the corresponding portion, if greater, equal or less than the given portion (according to
      a poster with color photos to illustrate the portion size of each food source of calcium).

      Consumption of glasses of milk and soda were also evaluated according to quantity and
      frequency (For milk, 0 = does not consume, 1 = consume < 1 cup per day, 2 = consume 1 to 2
      cups/day, and 3 = consume 3 or more cups of milk/day; for soda, 1 = consume daily, 2 =
      consume only on weekends or 2 times/week, 3 = consumes less than 1 day/week, and 4 = does not
      consume).

      Clinical Data Clinical data were obtained during the enrollment and included age, gender, OI
      type, use of bisphosphonates, and calcium intake.

      Anthropometric Data and Basal Metabolic Rate Anthropometric measurements (weight and height)
      were measured and evaluated according to the z-score proposed by the World Health
      Organization WHO. The length was measured in the supine position in children smaller than 1 m
      and children could not remain in the standing position. Patients over 1.04 m and unable to
      remain standing were measured in the supine position. BMI was calculated according to the
      WHO. The BMR was evaluated through indirect calorimetry and the data was published
      previously.

      Bone Mineral Density BMD was determined before and after the intervention using Dual Energy
      X-Ray Absorptiometry (DEXA) on a Lunar DXA (GE Healthcare, San Francisco, USA). Bone mineral
      content (BMC) (g), lumbar spine BMD (L1-L4), and total body BMC (TB) were calculated and
      expressed as z-scores.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Calcium intake
time frame: 12 months
description: Was assessed using an food frequency questionaire adapted to calcium intake
measure: Consumption of glasses of milk
time frame: 12 months
description: Evaluated according to quantity and frequency (For milk, 0 = does not consume, 1 = consume < 1 cup per day, 2 = consume 1 to 2 cups/day, and 3 = consume 3 or more cups of milk/day
measure: Body mass index
time frame: 12 months
description: Calculation divides an children's weight in kilograms by their height in metres squared.Evaluated according to the z-score proposed by the WHO (2006, 2007)
measure: Bone Mineral Density
time frame: 12 months
description: Bone mineral density was assessed thought Dual-energy X-ray absorptiometry
arm group label: Nutritional Orientation
arm group type: Other
description: The patients received a nutritional orientation with emphasis in food rich in calcium
intervention type: Other
intervention name: Nutritional orientation
description: Nutritional orientation with emphasis in rich calcium food
arm group label: Nutritional Orientation
criteria: 
gender: All
minimum age: N/A
maximum age: 19 Years
healthy volunteers: No
last name: Elza D Mello, MD, PhD
role: Principal Investigator
affiliation: Hospital de Clinicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Osteogenesis Imperfecta
sharing ipd: Undecided