Protocol summary
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Study aim
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to determine the effect of oral 25(OH)D on serum levels of 25(OH)D and association to the primary and secondary outcomes of COVID-19 infection in affected patients.
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Design
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double blind, randomised controlled trial
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Settings and conduct
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The project will perform in Sina hospital as a COVID-19 center.
Subjects including patients with positive COVID-19
Participants, physicians, data collectors, and project executives are blind to the type of medication (medication and placebo).
The coordinator will determine this with a computer-generated randomization program.
Each patient has a specific code. Based on the drug coding, the physician or researcher will provide the drug to the participant.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. COVID-19 positive in the patient group
Exclusion criteria:
1.Ongoing treatment with vitamin D metabolites or analogs or consuming medication affecting bone metabolism
2.History of chronic disorders such as hepatic or renal failure, malabsorption syndrome
3.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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Duration of infection
Dyspnea experience
duration of hospitalization
Admitted to ICU: duration
Incubation period
Lymphopenia
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 "Undecided" was updated 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:
IRCT20200401046909N1
Registration date:
2020-04-09, 1399/01/21
Registration timing:
prospective
Last update:
2020-06-01, 1399/03/12
Update count:
2
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Registration date
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2020-04-09, 1399/01/21
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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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2020-04-15, 1399/01/27
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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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The efficacy of oral 25-hydroxyvitamin D3 on COVID-19 treatment 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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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
2019-nCov (SARA-Cov-2) nucleic acid positive will be detected by PCR in affected patients
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 analogues
Pregnant or lactating women;
Severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.
History of elevated serum calcium >9.8 mg/dl)
Chronic hepatic or renal failure or patients with reduced kidney function, cancers, and malabsorption syndrome, a 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), as well as
those who are following special diets such as vegetarian diet or consuming fortified products regularly.
Subjects with a history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogues.
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:
260
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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 clinical trial, 260 patients with positive COVID-19 will be recruited. Patients will be randomly allocated to the drug group (N=130) and placebo group (N=130).
The randomization method is "restricted randomization". It will be determined by a "Random Allocation Software".
Subjects in the drug group will receive 1000 IUs of 25(OH)D daily for 8 wks and subjects in the placebo group will receive placebo daily for 8 wks.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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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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
Secondary outcomes
1
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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
2
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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 method
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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Treatment - Drugs
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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be 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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the primary outcome measures
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When the data will become available and for how long
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six months after publishing paper/ until 2 years after the end of the study
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To whom data/document is available
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Based on the Iran Ministry of a health condition related to clinical trials
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Under which criteria data/document could be used
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Based on Iran Ministry of Health condition related to clinical trials
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From where data/document is obtainable
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the email address of the principal investigator
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What processes are involved for a request to access data/document
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The request will be reviewed by the project executors and then Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran.
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Comments
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