Cholecalciferol to Improve the Outcomes of COVID-19 Patients

NCT ID: NCT04411446

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2021-07-28

Brief Summary

The recent inception of the coronavirus SARS-CoV-2, responsible for the coronavirus disease (COVID-19), has caused thousands of deaths globally. The most frequently reported complications among COVID-19 patients are from respiratory involvement.

Vitamin D has immunomodulatory effects that could protect against COVID-19 infection. Indeed, there is good evidence from randomized clinical trials suggesting that high doses of vitamin D administered during cold seasons prevent viral respiratory infections in at risk individual, and more recently, observational studies suggested that the mortality rate from COVID-19 is inversely correlated with levels of serum 25(OH)vitamin D.

The hypothesis of the study is that a high dose of vitamin D given orally to patients admitted to the hospital for COVID-19 will prevent the occurrence of respiratory deragement and other adverse clinical events.

To evaluate the aforementioned hypothesis, a randomized, controlled, double-blind, clinical trial comparing a 500.000 UI dose of vitamin D versus placebo among COVID-19 patients at moderate risk, requiring hospitalization but without requirements of critical care at admission was designed. The intervention will be one dose of 500.000 UI given orally or matching placebo.

The trial has a sequential design with two steps:

• The first step, projected to include 200 patients, will assess the effects of the intervention on the respiratory SOFA; and
• If there is a detectable effects, the second step, projected to include 1264 patients, will assess the effects on a combined event that includes need of high dose of oxygen or mechanical ventilation.

All study outcomes will be measured during the index hospitalization.

Detailed Description

See above.

Conditions

COVID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D

5 capsules containing 100.000 UI of vitamin D each. The intervention will be 5 capsules given in one-time oral intake.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

5 capsules of 100.000 UI Vitamin D orally given all at once. One dose.

Placebo

5 capsules containing placebo. The intervention will be 5 capsules given in one-time oral intake.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

5 capsules of containing placebo orally given all at once. One dose.

Interventions

Vitamin D

5 capsules of 100.000 UI Vitamin D orally given all at once. One dose.

Intervention Type: DRUG

Placebo

5 capsules of containing placebo orally given all at once. One dose.

Intervention Type: DRUG

Other Intervention Names

Cholecalciferol

Eligibility Criteria

Inclusion Criteria

• SARS-CoV-2 confirmed infection;
• Admission to a hospital;
• Expected hospitalization in the center for at least for 24 hs;
• Oxygen Saturation >90% breathing without oxygen supplement;
• Age at least 45 years or the presence of one of the followings risk factors:
• Hypertension;
• Diabetes (type I o II);
• At least moderate COPD or Asthma;
• Cardiovascular disease (history of myocardial infarction, coronary angioplasty, coronary artery bypass grafting or valve replacement surgery);
• Body Mass Index >=30;
• Signed Written consent.

Exclusion Criteria

• <18 years old;
• Women in childbearing age;
• >= 72 hs since current admission;
• Requirement for high dose of oxygen (>5 liters/minute) or mechanical ventilation (non-invasive or invasive);
• History of Chronic kidney disease requiring hemodialysis or chronic liver failure;
• Inability for oral intake;
• Previous treatment with pharmacological vitamin D;
• History of:
• previous treatment with anticonvulsants;
• sarcoidosis;
• malabsorption syndrome;
• Known hypercalcemia.
• Life expectancy less than 6 months;
• Known allergy to the study medication;
• Any condition impeding to bring informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agencia Nacional de Investigación y Desarrollo

OTHER

Sponsor Role: collaborator

Vitamin D Study Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Manucha, PhD

Role: STUDY_DIRECTOR

IMBECU, Univ Nac de Cuyo, Mendoza, Argentina

Carlos Tajer, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche

Laura Antonietti, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche

León Ferder, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides University

Felipe Inserra, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Maimónides - Hospital Universitario Austral

Javier Mariani, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche

Locations

Hospital de Alta Complejidad en Red El Cruce

San Juan Bautista, Buenos Aires, Argentina

Countries

Argentina

References

Martin Gimenez VM, Inserra F, Tajer CD, Mariani J, Ferder L, Reiter RJ, Manucha W. Lungs as target of COVID-19 infection: Protective common molecular mechanisms of vitamin D and melatonin as a new potential synergistic treatment. Life Sci. 2020 Aug 1;254:117808. doi: 10.1016/j.lfs.2020.117808. Epub 2020 May 15.

Reference Type: RESULT

PMID: 32422305 (View on PubMed)

Mariani J, Antonietti L, Tajer C, Ferder L, Inserra F, Sanchez Cunto M, Brosio D, Ross F, Zylberman M, Lopez DE, Luna Hisano C, Maristany Batisda S, Pace G, Salvatore A, Hogrefe JF, Turela M, Gaido A, Rodera B, Banega E, Iglesias ME, Rzepeski M, Gomez Portillo JM, Bertelli M, Vilela A, Heffner L, Annetta VL, Moracho L, Carmona M, Melito G, Martinez MJ, Luna G, Vensentini N, Manucha W. High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: Multicentre randomized controlled clinical trial. PLoS One. 2022 May 27;17(5):e0267918. doi: 10.1371/journal.pone.0267918. eCollection 2022.

Reference Type: DERIVED

PMID: 35622854 (View on PubMed)

Mariani J, Tajer C, Antonietti L, Inserra F, Ferder L, Manucha W. High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial (CARED-TRIAL). Trials. 2021 Feb 1;22(1):111. doi: 10.1186/s13063-021-05073-3.

Reference Type: DERIVED

PMID: 33522946 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id