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Vitamin D on Prevention and Treatment of COVID-19 (COVITD-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334005
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Castillo Garzón, Universidad de Granada

Brief Summary:
The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.

Condition or disease Intervention/treatment Phase
Patients Infected With COVID-19 Dietary Supplement: Vitamin D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
Estimated Study Start Date : April 10, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Usual care
Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.
Dietary Supplement: Vitamin D
The intervention group will receive a single dose of 25000 UI of vitamin D supplement in addition to prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. Vitamin D supplementation will be taken in the morning together with a toast with olive oil to facilitate its absorption.

Experimental: Intervention group
25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.
Dietary Supplement: Vitamin D
The intervention group will receive a single dose of 25000 UI of vitamin D supplement in addition to prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. Vitamin D supplementation will be taken in the morning together with a toast with olive oil to facilitate its absorption.




Primary Outcome Measures :
  1. Composite of cumulative death (i.e. mortality) for all causes and for specific causes. [ Time Frame: Through study completion, an average of 10 weeks ]

Secondary Outcome Measures :
  1. Necessity of invasive assisted ventilation [ Time Frame: Through study completion, an average of 10 weeks ]
  2. Necessity of non-invasive assisted ventilation [ Time Frame: Through study completion, an average of 10 weeks ]
  3. Intensive care unit admission [ Time Frame: Through study completion, an average of 10 weeks ]
  4. Post-anesthesia care unit admission [ Time Frame: Through study completion, an average of 10 weeks ]
  5. Hospital admission [ Time Frame: Through study completion, an average of 10 weeks ]
  6. Medical consultation [ Time Frame: Through study completion, an average of 10 weeks ]
  7. Home care and isolation time [ Time Frame: Through study completion, an average of 10 weeks ]
  8. Bed rest time [ Time Frame: Through study completion, an average of 10 weeks ]
  9. symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19) [ Time Frame: Through study completion, an average of 10 weeks ]
  10. Subjective perception of recovery [ Time Frame: Through study completion, an average of 10 weeks ]
    It will be measure by questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.

Exclusion Criteria:

  • Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334005


Contacts
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Contact: Manuel J Castillo, MD, PhD +34 649440850 mcgarzon@ugr.es

Locations
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Spain
Universidad de Granada
Granada, Andalucia, Spain, 18071
Contact: Manuel J. Castillo Garzón       mcgarzon@ugr.es   
Medicine Faculty
Granada, Spain, 18001
Contact: Proffesor Amaro Gahete, PhD student    697287022 ext +34    amarof@ugr.es   
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Manuel J Castillo, MD, PhD Universidad de Granada
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Responsible Party: Manuel Castillo Garzón, MD, PhD, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04334005    
Other Study ID Numbers: COVITD-19
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents