Protocol summary
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Study aim
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1. To determine the effect of oral supplementation by 25(OH)D on serum levels of 25(OH)D and relate this to decrease the incidence of Coronavirus infection in health providers and family members of COVID-19 patients
2. To determine the effect of oral supplementation by 25(OH)D on serum levels of 25(OH)D and relate this to the primary and secondary outcomes of Coronavirus infection in newly affected patients.
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Design
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A double-blind, randomized controlled trial
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Settings and conduct
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The project will perform in as COVID-19 centers affiliated to the Tehran University of medical sciences.
Subjects include health providers and the patients' relatives with negative COVID-19.
Subjects will be allocated to the intervention or placebo groups. The coordinator will determine this with a computer-generated randomization program. The coordinator does not involve the treatment process and data gathering and data analysis.
Participants, physicians, data collectors, and project executives are blind to the type of medication (intervention and placebo). Each patient has a specific code. Based on the drug coding, the physician or researcher will provide the drug to the subjects.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: not affected by COVID-19 (based on WHO criteria)
Exclusion criteria:
Ongoing treatment with vitamin D metabolites or analogs or consuming medication affecting bone metabolism
History of chronic disorders
Inability to give informed consent
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Intervention groups
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Subjects in the intervention group will receive 1000 IUs of 25(OH)D daily for 8 wks and controls will receive placebo daily for 8 wks.
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Main outcome variables
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1. The number of new cases with COVID-19
2.Duration of infection
3.Dyspnea experience
4.Duration of hospitalization
5.Admitted to ICU: duration
6.Incubation period
7.Lymphopenia
8.Mortality during 60 days of study
General information
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Reason for update
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In section Sharing plan:
The item "no plan" was changed to "Yes - there is a plan to make this available"
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200401046909N2
Registration date:
2020-04-11, 1399/01/23
Registration timing:
prospective
Last update:
2020-05-27, 1399/03/07
Update count:
2
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Registration date
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2020-04-11, 1399/01/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-14, 1399/01/26
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Expected recruitment end date
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2020-10-30, 1399/08/09
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating preventive effects of oral 25-hydroxyvitamin D3 on COVID-19 in adults: A Randomized, Controlled Double-Blind Clinical Trial.
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Public title
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Evaluation of the efficacy of oral 25-hydroxyvitamin D3 on COVID-19
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Non-infected with COVID-19 (based on WHO criteria)
Older than 17 years old and younger than 76 years old
No medications or disorders that would affect vitamin D metabolism
Women must be not pregnant at baseline and during study
Ability and willingness to give informed consent and comply with protocol requirements
Exclusion criteria:
Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogs
Pregnant or lactating women
Severe underlying diseases, such as an advanced malignant tumor, end-stage lung disease, etc.
History of elevated serum calcium levels more than 10.6 mg/dl
History of chronic hepatic, renal failure or patients with reduced kidney function, cancers, malabsorption syndrome, or granulomatous disorders such as Sarcoidosis or Tuberculosis
Supplementation with over the counter formulations of vitamin D2 or vitamin D3
Use of tanning bed or artificial UV exposure within the last two weeks
Consuming medication affecting bone metabolism (anti-convulsants, anti-tuberculosis medication, cimetidine, theophylline, and cholestyramine)
Following special diets such as vegetarian diet or consuming fortified products regularly
A history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs
Inability to give informed consent
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
540
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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in this study, the random allocation for intervention and placebo groups is based on a "Random Allocation Software".
A simple randomized list will be produced by the software for a sample size of 540 subjects into two groups of the intervention and placebo with equal sample size and numeric sequential unique.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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It is a double-blind clinical trial. Participants, physicians, data collectors, and project executives are blind to the type of medication (medication and placebo). The drug and placebo are coded by someone else. This person has no role in treatment, data collection and data analysis. The codes are randomly selected for each participant. Each patient has a specific code. Based on the drug coding, the physician or researcher will provide the drug to the participants. medication: containing 25OHD soft gelatin capsular placebo: containing white to off white color suspension oil
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-17, 1398/12/27
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.061
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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SARS-associated coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
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Description
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Affected by COVID-19
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Timepoint
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Sign of COVID-19 during study
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Method of measurement
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patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR)
Secondary outcomes
1
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Description
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Infection duration
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Timepoint
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During study
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Method of measurement
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WHO criteria
2
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Description
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Severity of disease (mild, moderate, sever)
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Timepoint
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During study
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Method of measurement
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Dyspnea, Palsoximethry result, CBC diff, Blood gas parameters, and acid-base, CT scan result
3
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Description
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Serum levels of Vitamin D
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Timepoint
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Before intervention, end of 4th and end of 8th intervention
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Method of measurement
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HPLC
Intervention groups
1
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Description
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Intervention group: containing 25OHD soft gelatin capsular 1000 IU , Producer: Dishmen. the case group will receive 1000 IUs of 25(OH)D daily for 8 wks. The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the 25(OH)D. The bottles will be returned to be checked at each visit.
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Category
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Prevention
2
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Description
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Placebo: containing white to off white color suspension oil. Producer: Dishmen Company. The control group will receive placebo daily for 8 wks..The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the placebo. The bottles will be returned to be checked at each visit.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Manuscripts will be published based on the project data
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When the data will become available and for how long
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End of study
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To whom data/document is available
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For all researchers and clinicians
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Under which criteria data/document could be used
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Based on the Iran Ministry of Health condition related to clinical trials
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From where data/document is obtainable
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Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran
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What processes are involved for a request to access data/document
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There is no further information.
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Comments
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