COVID-19 Lessons Learned: the Outcome of TOMEKA® Project is to Teach

NCT04424940 | Unknown

• 2 other identifiers: UKinshasaTshima Guyguy Kabundi
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

TOMEKA®; Treatment; COVID-19; Education

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-TOMEKA® usage as assessed by Education

  Change people's behaviour

  9 months

Secondary Outcomes (1)

• Change From Baseline in nutraceuticals usage on the care of the Covid-19 at 9 months

  9 months

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Age: 15-75 * Sex: M, F

You may qualify if:

• COVID-19 patients confirmed
• be regular on appointments

You may not qualify if:

• COVID-19 suspected clinically
• Children
• refuse to participate

Sponsors & Collaborators

• University of Kinshasa: lead
• University Ghent: collaborator
• Université de Montréal: collaborator

Study Sites (1)

Cliniques Universitaires de Kinshasa

Kinshasa, BP KIN XI, Democratic Republic of the Congo

Location

Related Publications (8)

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  RESULT

• Particularly elderly people are often selenium-deficient, which was proven to be the case in e.g. Italy

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

Related Links

• 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
• 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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GUYGUY KABUNDI TSHIMA, MD

  University of Kinshasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TSHIMA, MD

CONTACT

15143819264; guyguytshimakabundi@gmail.com

GUYGUY KABUNDI TSHIMA, MD

CONTACT

5143819264; guyguytshima@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 11, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the beginning of the study and follow-up
• Access Criteria: for free

Locations

DE (1)