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About
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.
Full description
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:
How it will be measured:
And at what time points it will be measured:
Objectives:
The hypothesis of investigators work:
Patients with COVID-19 have an increased demand for Selenium
Selenium supplementation reduces the viral rate
Selenium supplementation improves the BMI of COVID-19 patients
Selenium supplementation reduces COVID-19 related morbidity
Selenium supplementation postponed COVID-19 related mortality
Selenium supplementation is adjuncted to any form of COVID-19 therapy with nutrition education
Nutrition education improves health status
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
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.
Atypical geriatric signs
Other comments:
.......................................................................................................................... ........................................................................................................................................................................................................................................................................................................................................................................................................................................................
Assessment of mental state
Attention span: attentive, not attentive
State of consciousness: hyper-alert (or agitation), Lethargic (verbal), alert stupor (physical, comatose
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
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
Prescribed screening test (oro-nasopharyngeal sample): yes no
If the sample confirms the presence of COVID-19, isolate the patient in the warm unit.
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:
Links:
https://lnkd.in/eqAGhDH https://lnkd.in/epFKVEY
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Central trial contact
GUYGUY KABUNDI TSHIMA, MD; TSHIMA, MD
Data sourced from clinicaltrials.gov
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