<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/NCT04424940</url>
  </required_header>
  <id_info>
    <org_study_id>UKinshasa</org_study_id>
    <secondary_id>Tshima Guyguy Kabundi</secondary_id>
    <nct_id>NCT04424940</nct_id>
  </id_info>
  <brief_title>COVID-19 Lessons Learned: the Outcome of TOMEKA® Project is to Teach</brief_title>
  <acronym>MD</acronym>
  <official_title>TOMEKA® Project Was Sponsored by the University of Kinshasa: it's an Observational Study by Its Reviewed Documentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kinshasa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kinshasa</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Living in Canada and being health-worker in the first line face to COVID-19, investigator&#xD;
      outcome is to teach an experience or explain the disease using a review and get people&#xD;
      prepared to COVID-19 treatment focused on adherence to the HIV approved 2006-2007 protocol at&#xD;
      Ghent University but the review shows an older different study approved at the University of&#xD;
      Kinshasa and its ethics approval that again is an old document. So no ethics document&#xD;
      supporting the study exists as it is now and no registration. It is an observational study&#xD;
      and therefore would not usually require registration in order for the results to be&#xD;
      published. It is not a type of secondary literature. The formula TOMEKA® (Mix porridge of&#xD;
      maize, sorghum, and soya) follows FOOD + HEALTH CLAIM. It is scientifically justified,&#xD;
      relevantly used, and correctly communicated. Methodology: sufficient data? scientific&#xD;
      consensus? correct methodology? correct population? context: significant results? context of&#xD;
      use, realistic ingestion? correct target group? communication: consumer perception?&#xD;
      exaggerated/insinuative, clear, precise, complete, correct information? not misleading?&#xD;
      correctly presented? The product TOMEKA® tried to fulfill to above questions in a fitting way&#xD;
      with COVID-19 which is an emerging, rapidly evolving situation without a vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On 12/06/2020 worldwide, COVID-19 affected 7 273 958 confirmed cases with 413 372 deaths, 97&#xD;
      894 confirmed in Canada with 8 048 deaths, 53 666 confirmed cases in Quebec with 5 148&#xD;
      deaths, 4 637 confirmed cases with 101 deaths in the Democratic Republic of the Congo where&#xD;
      the situation is disastrous: an immense country and the ways of communication are difficult&#xD;
      and damaged. It becomes gymnastics to get a drug package.&#xD;
&#xD;
      The principal investigator provide the details of this study to be available to the public in&#xD;
      getting knowledge of Covid-19 and micronutrients using the product TOMEKA®.&#xD;
&#xD;
      The individual contribution of ingredients in the nutritional composition of TOMEKA® (mixed&#xD;
      flour). Composition of TOMEKA® (Clinical Research Protocol): 100 g of TOMEKA contain 20.1 g&#xD;
      of protein; 57.8 g of carbohydrates, 10.1 g of lipids; 8.5 mg iron; 117.6 mg Calcium; 16.6 mg&#xD;
      Sodium; 55 μg of Selenium and 378.6 kcal of energy.TOMEKA will be made with soy, maize,&#xD;
      sorghum. The above calculations were made with the food composition table (no laboratory&#xD;
      analyzes).&#xD;
&#xD;
      Quantity to be served per meal (in g): 30 g for 6-8 months (113,4 Kcal of Energy per served&#xD;
      meal). 40 g for 9-11 months (151 Kcal): 50 g for 12-23 months and more expecting to provide&#xD;
      189 Kcal of energy per served per meal. Each group needs 4-5 meals a day to get the&#xD;
      equivalent of their daily nutritional needs.&#xD;
&#xD;
      The study will focus on Selenium, a powerful non-enzymatic antioxidant, more powerful than&#xD;
      Vit C and Vit E combined. The formula TOMEKA® follows FOOD + HEALTH CLAIM.&#xD;
&#xD;
      A clear device to follow micronutrients and Covid-19 symptoms:&#xD;
&#xD;
      Example 1: Vitamin D and Covid-19 (Press release from the National Academy of Medicine in&#xD;
      France May 22, 2020) Vitamin D is a prohormone synthesized in the dermis under the effect of&#xD;
      ultraviolet rays, that is to say of the rays of the sun, then transported in the liver and&#xD;
      the kidney where it is transformed into an active hormone. It is responsible for the&#xD;
      intestinal absorption of calcium and bone health, but vitamin D also has unconventional&#xD;
      effects. In particular, it modulates the functioning of the immune system by stimulating&#xD;
      macrophages and dendritic cells [1,2,3]. It plays a role in regulating and suppressing the&#xD;
      cytokine inflammatory response which causes acute respiratory distress syndrome which&#xD;
      characterizes the severe and often lethal forms of Covid-19. A significant correlation&#xD;
      between low serum vitamin D levels and mortality by Covid-19 has been shown [4]. This&#xD;
      phenomenon generally follows a North-South gradient, although there are exceptions such as&#xD;
      the Nordic countries where the supplementation of the nutrients in vitamin D, in particular&#xD;
      milk products, is systematic. On the other hand, the countries of southern Europe&#xD;
      surprisingly display a high prevalence of vitamin D deficiency despite higher sunshine [5].&#xD;
      This would explain why children who receive vitamin D regularly have asymptomatic forms of&#xD;
      Covid-19 and fewer complications. Vitamin D cannot be considered as a preventive or curative&#xD;
      treatment for SARS-CoV-2 infection; but by mitigating the inflammatory storm and its&#xD;
      consequences, it could be considered as an adjunct to any form of therapy.&#xD;
&#xD;
      The National Academy of Medicine in France recalls that the administration of vitamin D&#xD;
      orally is a simple, inexpensive measure and reimbursed by Health Insurance; - confirms its&#xD;
      recommendation to ensure vitamin D supplementation in the French population in a report in&#xD;
      2012 [2]; - recommend that the serum vitamin D level (i.e. 25OHD) be measured quickly in&#xD;
      people over 60 years of age with Covid-19 and that it be administered in the event of a&#xD;
      deficiency, a loading dose of 50,000 to 100,000 IU which could help limit respiratory&#xD;
      complications; - recommends providing vitamin D supplementation of 800 to 1,000 IU / day in&#xD;
      people under the age of 60 as soon as the diagnosis of Covid-19 is confirmed.&#xD;
&#xD;
      Example 2: Selenium and Covid-19&#xD;
&#xD;
      Now is the time to give extra attention to a balanced diet and assure an optimum dietary&#xD;
      micronutrient and vitamin intake! Particularly the micronutrient selenium plays an essential&#xD;
      role in antioxidant functioning and helps to alleviate the negative health impacts of viral&#xD;
      infections, including inflammation of the lungs (see e.g. https://lnkd.in/eqAGhDH).&#xD;
&#xD;
      Particularly elderly people are often selenium-deficient, which was proven to be the case in&#xD;
      e.g. Italy (see https://lnkd.in/epFKVEY). However, when taking micronutrient and vitamin&#xD;
      supplements, also follow the instructions to avoid over-supplementation! A healthy and&#xD;
      balanced diet is the safest way towards an appropriate dietary micronutrient and vitamin&#xD;
      intake.&#xD;
&#xD;
      Description of what investigators will measure:&#xD;
&#xD;
        1. The Production of Medical Knowledge:&#xD;
&#xD;
        2. Learning medicine:&#xD;
&#xD;
      How it will be measured:&#xD;
&#xD;
        1. The Production of Medical Knowledge: Anthropology/Medicine. It is substantial and it&#xD;
           showed by the title.&#xD;
&#xD;
        2. Learning medicine: The clinical trial shows that medical anthropology connects&#xD;
           anthropology and social theory generally with some of the more significant questions of&#xD;
           our epoch with the COVID-19 pandemic.&#xD;
&#xD;
      And at what time points it will be measured:&#xD;
&#xD;
        1. The Production of Medical Knowledge: the principal investigator has received&#xD;
           notifications from Researchgate about 700 researchers who read his research theme, so it&#xD;
           deserves to be widely read and taught.&#xD;
&#xD;
        2. Learning medicine: This is an original trial, which combines theoretical argument with&#xD;
           empirical observation&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Investigators would like the participant to accept the notion that all knowledge is&#xD;
           socially and culturally constructed.&#xD;
&#xD;
        2. Investigators would examine the contexts in which that knowledge is produced talking on&#xD;
           the theme of nutrition in research and aiming to act in medicine, psychiatry,&#xD;
           epidemiology, and anthropology.&#xD;
&#xD;
        3. Investigators would like the participant acts in behavioral medicine, public health,&#xD;
           epidemiology, anthropology as well as .nutrition.&#xD;
&#xD;
      The hypothesis of investigators work:&#xD;
&#xD;
        1. Patients with COVID-19 have an increased demand for Selenium&#xD;
&#xD;
        2. Selenium supplementation reduces the viral rate&#xD;
&#xD;
        3. Selenium supplementation improves the BMI of COVID-19 patients&#xD;
&#xD;
        4. Selenium supplementation reduces COVID-19 related morbidity&#xD;
&#xD;
        5. Selenium supplementation postponed COVID-19 related mortality&#xD;
&#xD;
        6. Selenium supplementation is adjuncted to any form of COVID-19 therapy with nutrition&#xD;
           education&#xD;
&#xD;
        7. Nutrition education improves health status&#xD;
&#xD;
        8. Selenium supplementation and nutrition education should be incorporated into the global&#xD;
           Nutritional care and support of COVID-19 patients&#xD;
&#xD;
           Methodology: observational study using a questionnaire.&#xD;
&#xD;
           Study Population:&#xD;
&#xD;
           Age: 15-75&#xD;
&#xD;
           Sex: M, F&#xD;
&#xD;
           Inclusion Criteria:&#xD;
&#xD;
           Fulfill Inclusion criteria and accept:&#xD;
&#xD;
           The participant is asked on the symptoms of the COVID-19 with a questionnaire. If he/she&#xD;
           can write yes to any of these questions in order to be tested:&#xD;
&#xD;
           In the past 4 hours, have you taken any medicines for fever or headaches, such as&#xD;
           acetaminophen (Paracetamol, Tylenol, Tempra), ibuprofen (Advil, Motrin) or Aspirin?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           Do you have a thermometer to take your body temperature?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           If you don't have a thermometer, do you have any of the following symptoms: warm&#xD;
           forehead, muscle or joint pain, chills, general weakness?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you had trouble breathing or been short of breath?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you had chest pain?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           Do you have a cough? Or if you have a health condition that is causing you to cough, is&#xD;
           your cough worse than usual?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you had a sore throat?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you had a runny nose?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you felt a loss of smell (in the absence of nasal&#xD;
           congestion)?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you had diarrhea (three or more bowel movements)?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you had a headache?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           In the past 24 hours, have you felt more tired than usual and unable to carry out your&#xD;
           daily activities?&#xD;
&#xD;
           Yes&#xD;
&#xD;
           No&#xD;
&#xD;
           COVID-19 patients confirmed&#xD;
&#xD;
           be regular on appointments&#xD;
&#xD;
           Exclusion Criteria:&#xD;
&#xD;
           COVID-19 suspected clinically&#xD;
&#xD;
           Children&#xD;
&#xD;
           refuse to participate&#xD;
&#xD;
           Initial assessment for the exclusion of suspected Covid-19 cases:&#xD;
&#xD;
           - New or exacerbated cough: Yes/No&#xD;
&#xD;
           - Sore throat: Yes/No&#xD;
&#xD;
           - Fever: Yes/No&#xD;
&#xD;
           - Intestinal gastritis symptoms (Diarrhea, nausea or vomiting): Yes/No&#xD;
&#xD;
           - Anosmia (loss of smell) / Ageusia (loss of taste): Yes/No&#xD;
&#xD;
             -  Shortness of breath: Yes/No&#xD;
&#xD;
             -  Sputum production: Yes/No&#xD;
&#xD;
             -  Weakness: Yes/No&#xD;
&#xD;
             -  Headache: Yes/No&#xD;
&#xD;
             -  Myalgia / athralgia: Yes/No&#xD;
&#xD;
             -  Nasal congestion: Yes/No&#xD;
&#xD;
             -  Hemoptysis: Yes/No&#xD;
&#xD;
             -  Conjunctivitis: Yes/No&#xD;
&#xD;
           Comments:&#xD;
&#xD;
           If yes to any of these questions: rule out an acute health condition. If no acute cause&#xD;
           identified, consider the person as a probable case and transfer to the warm unit.&#xD;
&#xD;
      2. Atypical geriatric signs&#xD;
&#xD;
        -  Sudden loss of autonomy (less than 1 week)&#xD;
&#xD;
        -  Sudden change in mental state (over 1 week)&#xD;
&#xD;
        -  Sudden change in behavior (new behavior or cessation of behavior (less than 1 week)&#xD;
&#xD;
        -  Geriatric fever (Oral or rectal temperature greater than or equal to 37.8 C or if&#xD;
           increase of 1.1 C compared to the usual normal T)&#xD;
&#xD;
      Other comments:&#xD;
&#xD;
      …………………………………………………………………………………………………………..&#xD;
      .............................................................................................&#xD;
      .............................................................................................&#xD;
      .............................................................................................&#xD;
      .............................................................................................&#xD;
      ....................................................................&#xD;
&#xD;
      3. Physical examination inspection:&#xD;
&#xD;
        -  Assessment of mental state&#xD;
&#xD;
        -  Attention span: attentive, not attentive&#xD;
&#xD;
        -  State of consciousness: hyper-alert (or agitation), Lethargic (verbal), alert stupor&#xD;
           (physical, comatose&#xD;
&#xD;
           4. Basic settings:&#xD;
&#xD;
      Vital signs:&#xD;
&#xD;
      Pulse: ……… / min TA: .......... / ……………. T: ................ C (fever if bu oral or rectal&#xD;
      sup or equal 37.8 C or if 1.1 C increase compared to the usual normal T)&#xD;
&#xD;
      Breathing:&#xD;
&#xD;
      Frequency: ......... / min&#xD;
&#xD;
      Type: Abdominal chest&#xD;
&#xD;
      Amplitude: normal deep surface&#xD;
&#xD;
      Rhythm: regular irregular&#xD;
&#xD;
      Draw: yes no&#xD;
&#xD;
      Saturation (normal to 94% and +, unless otherwise indicated):&#xD;
&#xD;
      Saturation: ............% ambient AIr With O2 …… ..L / min&#xD;
&#xD;
      5. Auscultation:&#xD;
&#xD;
      Anterior side&#xD;
&#xD;
      Abnormal noise: Yes No&#xD;
&#xD;
      Name if possible:&#xD;
&#xD;
      Sibilant&#xD;
&#xD;
      Ronchis&#xD;
&#xD;
      Right bronchus (A)&#xD;
&#xD;
      Left bronchus (B)&#xD;
&#xD;
      Posterior side&#xD;
&#xD;
      Presence of abnormal noise:&#xD;
&#xD;
      Yes&#xD;
&#xD;
      No&#xD;
&#xD;
      Name if possible:&#xD;
&#xD;
      Sibilant&#xD;
&#xD;
      Crackling&#xD;
&#xD;
      Lower right row&#xD;
&#xD;
      Left lower lobe&#xD;
&#xD;
      6. Medical decision making&#xD;
&#xD;
      Prescribed screening test (oro-nasopharyngeal sample): yes no&#xD;
&#xD;
      If the sample confirms the presence of COVID-19, isolate the patient in the warm unit.&#xD;
&#xD;
      7. Clinical monitoring of COVID-19 confirmed or suspected&#xD;
&#xD;
      Stable patient&#xD;
&#xD;
      Respiratory rate : q 2h and as needed&#xD;
&#xD;
      SpO2 and Temperature: per day and as needed&#xD;
&#xD;
      Blood pressure and Cardiac frequency: per day&#xD;
&#xD;
      Unstable patient (having had an episode of respiratory distress)&#xD;
&#xD;
      Respiratory rate: every hour and as needed&#xD;
&#xD;
      SpO2 and Temperature: per day and as needed&#xD;
&#xD;
      Surname and first name of doctor&#xD;
&#xD;
      Permits&#xD;
&#xD;
      Signature&#xD;
&#xD;
      DD / MM / YYYY&#xD;
&#xD;
      HH: MM&#xD;
&#xD;
      References:&#xD;
&#xD;
        1. - Liu PT, Stenger S, et al. Toll like receptor triggering of a vitamin D mediated&#xD;
           humanantimicrobial response. Science, 2006, 311 : 1770.&#xD;
&#xD;
        2. - Rapport de l'Académie nationale de médecine. Statut vitaminique, rôle extra osseux&#xD;
           etbesoins quotidiens en vitamine D. Bull Acad Natle Med. 2012, 196, 1011.&#xD;
&#xD;
        3. - Laird E, Rhodes JM and Kenny RA. Vitamin D and inflammation : potential implications&#xD;
           for severity of Covid-19. Irish med J, 2020, 113 : 81.&#xD;
&#xD;
        4. - McCartney DM, Byrne DG. Optimisation of vitamin D status impact mortality fromSARS&#xD;
           -CoV-2 infection Irish Med J .2020 113 : 58.5- Lips P, Cashman KD, et al. Current&#xD;
           vitamin D status in European and Middle East countries and strategies to prevent vitamin&#xD;
           D deficiency : a position statement of the European Calcified Tissue Society. Eur J&#xD;
           Endocrinol, 2019, 180 : P23-P54.&#xD;
&#xD;
      Links:&#xD;
&#xD;
      https://lnkd.in/eqAGhDH https://lnkd.in/epFKVEY&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>9 Months</target_duration>
  <primary_outcome>
    <measure>Number of participants with treatment-TOMEKA® usage as assessed by Education</measure>
    <time_frame>9 months</time_frame>
    <description>Change people's behaviour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in nutraceuticals usage on the care of the Covid-19 at 9 months</measure>
    <time_frame>9 months</time_frame>
    <description>Change people's behaviour</description>
  </secondary_outcome>
  <enrollment type="Anticipated">800</enrollment>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        -  Age: 15-75&#xD;
&#xD;
          -  Sex: M, F&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfill Inclusion criteria and accept&#xD;
&#xD;
          -  COVID-19 patients confirmed&#xD;
&#xD;
          -  be regular on appointments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COVID-19 suspected clinically&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  refuse to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GUYGUY KABUNDI TSHIMA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kinshasa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>TSHIMA, MD</last_name>
    <phone>15143819264</phone>
    <email>guyguytshimakabundi@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>GUYGUY KABUNDI TSHIMA, MD</last_name>
    <phone>5143819264</phone>
    <email>guyguytshima@yahoo.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cliniques Universitaires de Kinshasa</name>
      <address>
        <city>Kinshasa</city>
        <zip>BP KIN XI</zip>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
    <contact>
      <last_name>GUYGUY K. TSHIMA, Dr.</last_name>
      <phone>0015143819264</phone>
      <email>guyguytshimakabundi@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Congo, The Democratic Republic of the</country>
  </location_countries>
  <link>
    <url>https://lnkd.in/eqAGhDH</url>
    <description>Guillin OM, Vindry C, Ohlmann T, Chavatte L. Selenium, Selenoproteins and Viral Infection. Nutrients. 2019;11(9):2101. Published 2019 Sep 4. doi:10.3390/nu11092101</description>
  </link>
  <link>
    <url>https://lnkd.in/epFKVEY</url>
    <description>Lauretani F, Semba RD, Bandinelli S, et al. Low plasma selenium concentrations and mortality among older community-dwelling adults: the InCHIANTI Study. Aging Clin Exp Res. 2008;20(2):153-158. doi:10.1007/BF03324762</description>
  </link>
  <reference>
    <citation>This phenomenon generally follows a North-South gradient, although there are exceptions such as the Nordic countries where the supplementation of the nutrients in vitamin D, in particular milk products, is systematic. On the other hand, the countries of southern Europe surprisingly display a high prevalence of vitamin D deficiency despite higher sunshine</citation>
  </reference>
  <reference>
    <citation>This would explain why children who receive vitamin D regularly have asymptomatic forms of Covid-19 and fewer complications. Vitamin D cannot be considered as a preventive or curative treatment for SARS-CoV-2 infection; but by mitigating the inflammatory storm and its consequences, it could be considered as an adjunct to any form of therapy.</citation>
  </reference>
  <reference>
    <citation>The National Academy of Medicine in France recalls that the administration of vitamin D orally is a simple, inexpensive measure and reimbursed by Health Insurance; - confirms its recommendation to ensure vitamin D supplementation in the French population in a report in 2012 [2]; - recommend that the serum vitamin D level (i.e. 25OHD) be measured quickly in people over 60 years of age with Covid-19, and that it be administered in the event of a deficiency , a loading dose of 50,000 to 100,000 IU which could help limit respiratory complications; - recommends providing vitamin D supplementation of 800 to 1,000 IU / day in people under the age of 60 as soon as the diagnosis of Covid-19 is confirmed.</citation>
  </reference>
  <results_reference>
    <citation>Now is the time to give extra attention to a balanced diet and assure an optimum dietary micronutrient and vitamin intake! Particularly the micronutrient selenium plays an essential role in antioxidant functioning and helps to alleviate negative health impacts of viral infections, including inflammation of the lungs</citation>
  </results_reference>
  <results_reference>
    <citation>Particularly elderly people are often selenium-deficient, which was proven to be the case in e.g. Italy</citation>
  </results_reference>
  <results_reference>
    <citation>However, when taking micronutrient and vitamin supplements, also follow the instructions to avoid over-supplementation! A healthy and balanced diet is the safest way towards an appropriate dietary micronutrient and vitamin intake.</citation>
  </results_reference>
  <results_reference>
    <citation>Vitamin D is a prohormone synthesized in the dermis under the effect of ultraviolet rays, that is to say of the rays of the sun, then transported in the liver and the kidney where it is transformed into an active hormone. It is responsible for the intestinal absorption of calcium and bone health, but vitamin D also has unconventional effects. In particular, it modulates the functioning of the immune system by stimulating macrophages and dendritic cells.</citation>
  </results_reference>
  <results_reference>
    <citation>It plays a role in regulating and suppressing the cytokine inflammatory response which causes acute respiratory distress syndrome which characterizes the severe and often lethal forms of Covid-19. A significant correlation between low serum vitamin D levels and mortality by Covid-19 has been shown.</citation>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 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>University of Kinshasa</investigator_affiliation>
    <investigator_full_name>Guyguy K Tshima, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>TOMEKA®</keyword>
  <keyword>Treatment</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Through researchgate website</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>At the beginning of the study and follow-up</ipd_time_frame>
    <ipd_access_criteria>for free</ipd_access_criteria>
    <ipd_url>https://www.researchgate.net/publication/319997498_A_prospective_study_on_weight_evolution_of_people_living_with_HIV-AIDS_under_antiretroviral_drugs_in_malaria_endemic_areas</ipd_url>
  </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/NCT04424940
org study id: UKinshasa
secondary id: Tshima Guyguy Kabundi
nct id: NCT04424940
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Living in Canada and being health-worker in the first line face to COVID-19, investigator
      outcome is to teach an experience or explain the disease using a review and get people
      prepared to COVID-19 treatment focused on adherence to the HIV approved 2006-2007 protocol at
      Ghent University but the review shows an older different study approved at the University of
      Kinshasa and its ethics approval that again is an old document. So no ethics document
      supporting the study exists as it is now and no registration. It is an observational study
      and therefore would not usually require registration in order for the results to be
      published. It is not a type of secondary literature. The formula TOMEKA® (Mix porridge of
      maize, sorghum, and soya) follows FOOD + HEALTH CLAIM. It is scientifically justified,
      relevantly used, and correctly communicated. Methodology: sufficient data? scientific
      consensus? correct methodology? correct population? context: significant results? context of
      use, realistic ingestion? correct target group? communication: consumer perception?
      exaggerated/insinuative, clear, precise, complete, correct information? not misleading?
      correctly presented? The product TOMEKA® tried to fulfill to above questions in a fitting way
      with COVID-19 which is an emerging, rapidly evolving situation without a vaccine.
On 12/06/2020 worldwide, COVID-19 affected 7 273 958 confirmed cases with 413 372 deaths, 97
      894 confirmed in Canada with 8 048 deaths, 53 666 confirmed cases in Quebec with 5 148
      deaths, 4 637 confirmed cases with 101 deaths in the Democratic Republic of the Congo where
      the situation is disastrous: an immense country and the ways of communication are difficult
      and damaged. It becomes gymnastics to get a drug package.

      The principal investigator provide the details of this study to be available to the public in
      getting knowledge of Covid-19 and micronutrients using the product TOMEKA®.

      The individual contribution of ingredients in the nutritional composition of TOMEKA® (mixed
      flour). Composition of TOMEKA® (Clinical Research Protocol): 100 g of TOMEKA contain 20.1 g
      of protein; 57.8 g of carbohydrates, 10.1 g of lipids; 8.5 mg iron; 117.6 mg Calcium; 16.6 mg
      Sodium; 55 μg of Selenium and 378.6 kcal of energy.TOMEKA will be made with soy, maize,
      sorghum. The above calculations were made with the food composition table (no laboratory
      analyzes).

      Quantity to be served per meal (in g): 30 g for 6-8 months (113,4 Kcal of Energy per served
      meal). 40 g for 9-11 months (151 Kcal): 50 g for 12-23 months and more expecting to provide
      189 Kcal of energy per served per meal. Each group needs 4-5 meals a day to get the
      equivalent of their daily nutritional needs.

      The study will focus on Selenium, a powerful non-enzymatic antioxidant, more powerful than
      Vit C and Vit E combined. The formula TOMEKA® follows FOOD + HEALTH CLAIM.

      A clear device to follow micronutrients and Covid-19 symptoms:

      Example 1: Vitamin D and Covid-19 (Press release from the National Academy of Medicine in
      France May 22, 2020) Vitamin D is a prohormone synthesized in the dermis under the effect of
      ultraviolet rays, that is to say of the rays of the sun, then transported in the liver and
      the kidney where it is transformed into an active hormone. It is responsible for the
      intestinal absorption of calcium and bone health, but vitamin D also has unconventional
      effects. In particular, it modulates the functioning of the immune system by stimulating
      macrophages and dendritic cells [1,2,3]. It plays a role in regulating and suppressing the
      cytokine inflammatory response which causes acute respiratory distress syndrome which
      characterizes the severe and often lethal forms of Covid-19. A significant correlation
      between low serum vitamin D levels and mortality by Covid-19 has been shown [4]. This
      phenomenon generally follows a North-South gradient, although there are exceptions such as
      the Nordic countries where the supplementation of the nutrients in vitamin D, in particular
      milk products, is systematic. On the other hand, the countries of southern Europe
      surprisingly display a high prevalence of vitamin D deficiency despite higher sunshine [5].
      This would explain why children who receive vitamin D regularly have asymptomatic forms of
      Covid-19 and fewer complications. Vitamin D cannot be considered as a preventive or curative
      treatment for SARS-CoV-2 infection; but by mitigating the inflammatory storm and its
      consequences, it could be considered as an adjunct to any form of therapy.

      The National Academy of Medicine in France recalls that the administration of vitamin D
      orally is a simple, inexpensive measure and reimbursed by Health Insurance; - confirms its
      recommendation to ensure vitamin D supplementation in the French population in a report in
      2012 [2]; - recommend that the serum vitamin D level (i.e. 25OHD) be measured quickly in
      people over 60 years of age with Covid-19 and that it be administered in the event of a
      deficiency, a loading dose of 50,000 to 100,000 IU which could help limit respiratory
      complications; - recommends providing vitamin D supplementation of 800 to 1,000 IU / day in
      people under the age of 60 as soon as the diagnosis of Covid-19 is confirmed.

      Example 2: Selenium and Covid-19

      Now is the time to give extra attention to a balanced diet and assure an optimum dietary
      micronutrient and vitamin intake! Particularly the micronutrient selenium plays an essential
      role in antioxidant functioning and helps to alleviate the negative health impacts of viral
      infections, including inflammation of the lungs (see e.g. https://lnkd.in/eqAGhDH).

      Particularly elderly people are often selenium-deficient, which was proven to be the case in
      e.g. Italy (see https://lnkd.in/epFKVEY). However, when taking micronutrient and vitamin
      supplements, also follow the instructions to avoid over-supplementation! A healthy and
      balanced diet is the safest way towards an appropriate dietary micronutrient and vitamin
      intake.

      Description of what investigators will measure:

        1. The Production of Medical Knowledge:

        2. Learning medicine:

      How it will be measured:

        1. The Production of Medical Knowledge: Anthropology/Medicine. It is substantial and it
           showed by the title.

        2. Learning medicine: The clinical trial shows that medical anthropology connects
           anthropology and social theory generally with some of the more significant questions of
           our epoch with the COVID-19 pandemic.

      And at what time points it will be measured:

        1. The Production of Medical Knowledge: the principal investigator has received
           notifications from Researchgate about 700 researchers who read his research theme, so it
           deserves to be widely read and taught.

        2. Learning medicine: This is an original trial, which combines theoretical argument with
           empirical observation

      Objectives:

        1. Investigators would like the participant to accept the notion that all knowledge is
           socially and culturally constructed.

        2. Investigators would examine the contexts in which that knowledge is produced talking on
           the theme of nutrition in research and aiming to act in medicine, psychiatry,
           epidemiology, and anthropology.

        3. Investigators would like the participant acts in behavioral medicine, public health,
           epidemiology, anthropology as well as .nutrition.

      The hypothesis of investigators work:

        1. Patients with COVID-19 have an increased demand for Selenium

        2. Selenium supplementation reduces the viral rate

        3. Selenium supplementation improves the BMI of COVID-19 patients

        4. Selenium supplementation reduces COVID-19 related morbidity

        5. Selenium supplementation postponed COVID-19 related mortality

        6. Selenium supplementation is adjuncted to any form of COVID-19 therapy with nutrition
           education

        7. Nutrition education improves health status

        8. Selenium supplementation and nutrition education should be incorporated into the global
           Nutritional care and support of COVID-19 patients

           Methodology: observational study using a questionnaire.

           Study Population:

           Age: 15-75

           Sex: M, F

           Inclusion Criteria:

           Fulfill Inclusion criteria and accept:

           The participant is asked on the symptoms of the COVID-19 with a questionnaire. If he/she
           can write yes to any of these questions in order to be tested:

           In the past 4 hours, have you taken any medicines for fever or headaches, such as
           acetaminophen (Paracetamol, Tylenol, Tempra), ibuprofen (Advil, Motrin) or Aspirin?

           Yes

           No

           Do you have a thermometer to take your body temperature?

           Yes

           No

           If you don't have a thermometer, do you have any of the following symptoms: warm
           forehead, muscle or joint pain, chills, general weakness?

           Yes

           No

           In the past 24 hours, have you had trouble breathing or been short of breath?

           Yes

           No

           In the past 24 hours, have you had chest pain?

           Yes

           No

           Do you have a cough? Or if you have a health condition that is causing you to cough, is
           your cough worse than usual?

           Yes

           No

           In the past 24 hours, have you had a sore throat?

           Yes

           No

           In the past 24 hours, have you had a runny nose?

           Yes

           No

           In the past 24 hours, have you felt a loss of smell (in the absence of nasal
           congestion)?

           Yes

           No

           In the past 24 hours, have you had diarrhea (three or more bowel movements)?

           Yes

           No

           In the past 24 hours, have you had a headache?

           Yes

           No

           In the past 24 hours, have you felt more tired than usual and unable to carry out your
           daily activities?

           Yes

           No

           COVID-19 patients confirmed

           be regular on appointments

           Exclusion Criteria:

           COVID-19 suspected clinically

           Children

           refuse to participate

           Initial assessment for the exclusion of suspected Covid-19 cases:

           - New or exacerbated cough: Yes/No

           - Sore throat: Yes/No

           - Fever: Yes/No

           - Intestinal gastritis symptoms (Diarrhea, nausea or vomiting): Yes/No

           - Anosmia (loss of smell) / Ageusia (loss of taste): Yes/No

             -  Shortness of breath: Yes/No

             -  Sputum production: Yes/No

             -  Weakness: Yes/No

             -  Headache: Yes/No

             -  Myalgia / athralgia: Yes/No

             -  Nasal congestion: Yes/No

             -  Hemoptysis: Yes/No

             -  Conjunctivitis: Yes/No

           Comments:

           If yes to any of these questions: rule out an acute health condition. If no acute cause
           identified, consider the person as a probable case and transfer to the warm unit.

      2. Atypical geriatric signs

        -  Sudden loss of autonomy (less than 1 week)

        -  Sudden change in mental state (over 1 week)

        -  Sudden change in behavior (new behavior or cessation of behavior (less than 1 week)

        -  Geriatric fever (Oral or rectal temperature greater than or equal to 37.8 C or if
           increase of 1.1 C compared to the usual normal T)

      Other comments:

      …………………………………………………………………………………………………………..
      .............................................................................................
      .............................................................................................
      .............................................................................................
      .............................................................................................
      ....................................................................

      3. Physical examination inspection:

        -  Assessment of mental state

        -  Attention span: attentive, not attentive

        -  State of consciousness: hyper-alert (or agitation), Lethargic (verbal), alert stupor
           (physical, comatose

           4. Basic settings:

      Vital signs:

      Pulse: ……… / min TA: .......... / ……………. T: ................ C (fever if bu oral or rectal
      sup or equal 37.8 C or if 1.1 C increase compared to the usual normal T)

      Breathing:

      Frequency: ......... / min

      Type: Abdominal chest

      Amplitude: normal deep surface

      Rhythm: regular irregular

      Draw: yes no

      Saturation (normal to 94% and +, unless otherwise indicated):

      Saturation: ............% ambient AIr With O2 …… ..L / min

      5. Auscultation:

      Anterior side

      Abnormal noise: Yes No

      Name if possible:

      Sibilant

      Ronchis

      Right bronchus (A)

      Left bronchus (B)

      Posterior side

      Presence of abnormal noise:

      Yes

      No

      Name if possible:

      Sibilant

      Crackling

      Lower right row

      Left lower lobe

      6. Medical decision making

      Prescribed screening test (oro-nasopharyngeal sample): yes no

      If the sample confirms the presence of COVID-19, isolate the patient in the warm unit.

      7. Clinical monitoring of COVID-19 confirmed or suspected

      Stable patient

      Respiratory rate : q 2h and as needed

      SpO2 and Temperature: per day and as needed

      Blood pressure and Cardiac frequency: per day

      Unstable patient (having had an episode of respiratory distress)

      Respiratory rate: every hour and as needed

      SpO2 and Temperature: per day and as needed

      Surname and first name of doctor

      Permits

      Signature

      DD / MM / YYYY

      HH: MM

      References:

        1. - Liu PT, Stenger S, et al. Toll like receptor triggering of a vitamin D mediated
           humanantimicrobial response. Science, 2006, 311 : 1770.

        2. - Rapport de l'Académie nationale de médecine. Statut vitaminique, rôle extra osseux
           etbesoins quotidiens en vitamine D. Bull Acad Natle Med. 2012, 196, 1011.

        3. - Laird E, Rhodes JM and Kenny RA. Vitamin D and inflammation : potential implications
           for severity of Covid-19. Irish med J, 2020, 113 : 81.

        4. - McCartney DM, Byrne DG. Optimisation of vitamin D status impact mortality fromSARS
           -CoV-2 infection Irish Med J .2020 113 : 58.5- Lips P, Cashman KD, et al. Current
           vitamin D status in European and Middle East countries and strategies to prevent vitamin
           D deficiency : a position statement of the European Calcified Tissue Society. Eur J
           Endocrinol, 2019, 180 : P23-P54.

      Links:

      https://lnkd.in/eqAGhDH https://lnkd.in/epFKVEY
observational model: Cohort
time perspective: Prospective
measure: Number of participants with treatment-TOMEKA® usage as assessed by Education
time frame: 9 months
description: Change people's behaviour
measure: Change From Baseline in nutraceuticals usage on the care of the Covid-19 at 9 months
time frame: 9 months
description: Change people's behaviour
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GUYGUY KABUNDI TSHIMA, MD
role: Principal Investigator
affiliation: University of Kinshasa
last name: TSHIMA, MD
phone: 15143819264
email: guyguytshimakabundi@gmail.com
last name: GUYGUY KABUNDI TSHIMA, MD
phone: 5143819264
email: guyguytshima@yahoo.fr
facility: 
contact: 
country: Congo, The Democratic Republic of the
url: https://lnkd.in/eqAGhDH
description: Guillin OM, Vindry C, Ohlmann T, Chavatte L. Selenium, Selenoproteins and Viral Infection. Nutrients. 2019;11(9):2101. Published 2019 Sep 4. doi:10.3390/nu11092101
url: https://lnkd.in/epFKVEY
description: Lauretani F, Semba RD, Bandinelli S, et al. Low plasma selenium concentrations and mortality among older community-dwelling adults: the InCHIANTI Study. Aging Clin Exp Res. 2008;20(2):153-158. doi:10.1007/BF03324762
citation: This phenomenon generally follows a North-South gradient, although there are exceptions such as the Nordic countries where the supplementation of the nutrients in vitamin D, in particular milk products, is systematic. On the other hand, the countries of southern Europe surprisingly display a high prevalence of vitamin D deficiency despite higher sunshine
citation: This would explain why children who receive vitamin D regularly have asymptomatic forms of Covid-19 and fewer complications. Vitamin D cannot be considered as a preventive or curative treatment for SARS-CoV-2 infection; but by mitigating the inflammatory storm and its consequences, it could be considered as an adjunct to any form of therapy.
citation: The National Academy of Medicine in France recalls that the administration of vitamin D orally is a simple, inexpensive measure and reimbursed by Health Insurance; - confirms its recommendation to ensure vitamin D supplementation in the French population in a report in 2012 [2]; - recommend that the serum vitamin D level (i.e. 25OHD) be measured quickly in people over 60 years of age with Covid-19, and that it be administered in the event of a deficiency , a loading dose of 50,000 to 100,000 IU which could help limit respiratory complications; - recommends providing vitamin D supplementation of 800 to 1,000 IU / day in people under the age of 60 as soon as the diagnosis of Covid-19 is confirmed.
citation: Now is the time to give extra attention to a balanced diet and assure an optimum dietary micronutrient and vitamin intake! Particularly the micronutrient selenium plays an essential role in antioxidant functioning and helps to alleviate negative health impacts of viral infections, including inflammation of the lungs
citation: Particularly elderly people are often selenium-deficient, which was proven to be the case in e.g. Italy
citation: However, when taking micronutrient and vitamin supplements, also follow the instructions to avoid over-supplementation! A healthy and balanced diet is the safest way towards an appropriate dietary micronutrient and vitamin intake.
citation: Vitamin D is a prohormone synthesized in the dermis under the effect of ultraviolet rays, that is to say of the rays of the sun, then transported in the liver and the kidney where it is transformed into an active hormone. It is responsible for the intestinal absorption of calcium and bone health, but vitamin D also has unconventional effects. In particular, it modulates the functioning of the immune system by stimulating macrophages and dendritic cells.
citation: It plays a role in regulating and suppressing the cytokine inflammatory response which causes acute respiratory distress syndrome which characterizes the severe and often lethal forms of Covid-19. A significant correlation between low serum vitamin D levels and mortality by Covid-19 has been shown.
responsible party type: Principal Investigator
investigator affiliation: University of Kinshasa
investigator full name: Guyguy K Tshima, MD
investigator title: Principal Investigator
mesh term: COVID-19
sharing ipd: Yes
ipd description: Through researchgate website
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: At the beginning of the study and follow-up
ipd access criteria: for free
ipd url: https://www.researchgate.net/publication/319997498_A_prospective_study_on_weight_evolution_of_people_living_with_HIV-AIDS_under_antiretroviral_drugs_in_malaria_endemic_areas