<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/NCT04434014</url>
  </required_header>
  <id_info>
    <org_study_id>12345678</org_study_id>
    <nct_id>NCT04434014</nct_id>
  </id_info>
  <brief_title>Proper Nutrition And Its Relation To Oral Diseases In Covid -19 Era</brief_title>
  <official_title>Proper Nutrition and Its Relationship to Oral Diseases in the Era of Corona</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>October University for Modern Sciences and Arts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>October University for Modern Sciences and Arts</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      effect of proper diet and vitamins on the oral health and the regeneration of the taste and&#xD;
      smell in Covid 19 patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      effect of proper diet and vitamins on the oral health ( bleeding gums, ulcers, bad breath)&#xD;
      also the effect of proper diet on the regeneration of the taste and smell in Covid 19&#xD;
      patients A diet will be followed for 2 weeks then the progress will be evaluated by making&#xD;
      another questionnaire&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">June 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>regeneration of taste</measure>
    <time_frame>2 weeks</time_frame>
    <description>counting the fungiform papillae in 1cm x 1cm area of the tongue during the infection and after being cured</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Diet, Healthy</condition>
  <arm_group>
    <arm_group_label>males from 20 to above 65 y</arm_group_label>
    <description>will be sub divided into 4 groups according to age sub group I from 20 - 35 sub group II from 36- 45 sub group III from 46- 65 sub group IV more than 65</description>
  </arm_group>
  <arm_group>
    <arm_group_label>female from 20 to above 65 y</arm_group_label>
    <description>will be sub divided into 4 groups according to age will be sub divided into 4 groups according to age sub group I from 20 - 35 sub group II from 36- 45 sub group III from 46- 65 sub group IV more than 65</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>proper diet</intervention_name>
    <description>diet containing all essential vitamins</description>
    <arm_group_label>female from 20 to above 65 y</arm_group_label>
    <arm_group_label>males from 20 to above 65 y</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  the participants will answer a questionnaire then a diet will be sent to the&#xD;
             participants&#xD;
&#xD;
          -  the participants will follow the sent diet for 2 weeks then another questionnaire will&#xD;
             be sent to the participants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Samah Kamel, A .Prof</last_name>
    <phone>0020201112230444</phone>
    <email>sabdelaziz@msa.eun.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lecturer Mona abdelmoteleb</last_name>
    <phone>0020201001530834</phone>
    <email>mmoteleb@msa.eun.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>October university of modern sciences and arts</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samah Mohamed Kamel, A.Prof</last_name>
      <phone>0020201112230444</phone>
      <email>sabdelaziz@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>lecturer Mona Abdelmoteleb</last_name>
      <email>mmoteleb@msa.eun.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>October University for Modern Sciences and Arts</investigator_affiliation>
    <investigator_full_name>Samah Mohamed Kamel</investigator_full_name>
    <investigator_title>associate professr</investigator_title>
  </responsible_party>
  <keyword>Proper Diet</keyword>
  <keyword>Taste</keyword>
  <keyword>Oral Health</keyword>
  <keyword>Corona</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04434014
org study id: 12345678
nct id: NCT04434014
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
effect of proper diet and vitamins on the oral health and the regeneration of the taste and
      smell in Covid 19 patients
effect of proper diet and vitamins on the oral health ( bleeding gums, ulcers, bad breath)
      also the effect of proper diet on the regeneration of the taste and smell in Covid 19
      patients A diet will be followed for 2 weeks then the progress will be evaluated by making
      another questionnaire
observational model: Ecologic or Community
time perspective: Prospective
measure: regeneration of taste
time frame: 2 weeks
description: counting the fungiform papillae in 1cm x 1cm area of the tongue during the infection and after being cured
arm group label: males from 20 to above 65 y
description: will be sub divided into 4 groups according to age sub group I from 20 - 35 sub group II from 36- 45 sub group III from 46- 65 sub group IV more than 65
arm group label: female from 20 to above 65 y
description: will be sub divided into 4 groups according to age will be sub divided into 4 groups according to age sub group I from 20 - 35 sub group II from 36- 45 sub group III from 46- 65 sub group IV more than 65
intervention type: Dietary Supplement
intervention name: proper diet
description: diet containing all essential vitamins
arm group label: female from 20 to above 65 y
arm group label: males from 20 to above 65 y
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samah Kamel, A .Prof
phone: 0020201112230444
email: sabdelaziz@msa.eun.eg
last name: Lecturer Mona abdelmoteleb
phone: 0020201001530834
email: mmoteleb@msa.eun.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: October University for Modern Sciences and Arts
investigator full name: Samah Mohamed Kamel
investigator title: associate professr
mesh term: Mouth Diseases
sharing ipd: No