Protocol summary
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Study aim
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This study aims to evaluate the effect of vitamin D and magnesium supplementation on clinical symptoms, inflammatory markers, and oxidative stress in patients with Covid-19.
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Design
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This study is a double-blind clinical trial with a factorial design and the intervention period will be 3 weeks. The participants will be divided into four groups of 26 people and a random block design will be used for randomization.
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Settings and conduct
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This study will be conducted on 104 people aged 18 to 65 with Covid-19 admitted to the Shahid Mohammadi hospital in Bandar Abbas city that be eligible for inclusion in the study.
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Participants/Inclusion and exclusion criteria
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People aged 18-65, confirmation of Covid-19 by RT-PCR test, completing informed consent, less than 48 hours have passed since the patient was hospitalized, no skin or gastrointestinal allergies due to taking multivitamin supplements, vitamin D, and magnesium, people with more than 30 breaths per minute and less than 93% oxygen saturation in room air and sea level.
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Intervention groups
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A) Vitamin D (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium supplement (300 mg/day). B) Vitamin D supplement and magnesium placebo. C) Magnesium supplement and vitamin D placebo. D) Vitamin D placebo and magnesium placebo.
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Main outcome variables
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Clinical outcomes (fever, dry cough, shortness of breath, headache, myalgia, and oxygen saturation) and laboratory markers (MDA, TAC, WBC, neutrophils count, lymphocytes count, levels of 25 hydroxyvitamin D and magnesium)
General information
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Reason for update
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In the section of randomization description, the order of codes A, B, C, and D in a number of blocks are not written correctly, which need to be edited and corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210702051763N1
Registration date:
2021-08-14, 1400/05/23
Registration timing:
prospective
Last update:
2022-05-07, 1401/02/17
Update count:
2
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Registration date
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2021-08-14, 1400/05/23
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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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2021-08-23, 1400/06/01
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Expected recruitment end date
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2022-08-23, 1401/06/01
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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 effect of vitamin D and magnesium supplementation on clinical symptoms, inflammatory markers and oxidative stress in patients with COVID-19: double-blind randomized control clinical trial
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Public title
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The effect of vitamin D and magnesium supplementation on patients with 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:
People aged 18-65
confirmation of Covid-19 infection by RT-PCR test
completing informed consent
less than 48 hours have passed since the patient was hospitalized
no skin or gastrointestinal allergies due to taking multivitamin supplements, vitamin D, and magnesium
people with more than 30 breaths per minute and less than 93% oxygen saturation in room air and sea level.
Exclusion criteria:
Pregnancy or lactation
take a daily multivitamin or take a vitamin D or magnesium supplement in the last month
participating in other clinical studies
renal failure or dialysis, severe liver disease or cirrhosis
known diagnosis of hypercalcemia
patients who discharged from the hospital less than 24 hours after the start of the intervention
history of kidney stones in the last year
transfer the patient to the ICU
baseline vitamin D levels above 80 ng/ml
baseline magnesium levels above 2.6 mg/dl.
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Age
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From 18 years old to 65 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
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Sample size
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Target sample size:
104
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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, a random block design will be used for randomization. In this way, 24 blocks of 4 will be made using codes A, B, C, and D that these blocks will be numbered from 1 to 24 (ABCD, ACBD, ABDC, ADBC, ACDB, ADCB, BACD, BCAD, BADC, BDAC, BCDA, BDCA, CABD, CBAD, CADB, CDAB, CBDA, CDBA, DABC, DBAC, DACB, DCAB, DBCA, DCBA) and then using R software, twenty-six blocks from blocks 1 to 24 are randomly selected.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Vitamin D supplement and placebo will be provided by Zahravi Pharmaceutical Company (Iran). Magnesium placebo will be made from starch with the same color and shape as the magnesium supplement by the Faculty of Pharmacy of Hormozgan University of Medical Sciences. In this study, blinding of participants, staff, and investigators will be done (Magnesium and Vitamin D supplements and placebos will be placed in the same package with codes of A, B, C, and D by a responsible person who is not aware of the study objectives. The codes will not be available to researchers until after statistical analysis. In order to blind the participants, they will be explained at the beginning of the study who will receive one of four types of intervention and will not be told the exact type of supplement.
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Placebo
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Used
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Assignment
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Factorial
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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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2021-05-30, 1400/03/09
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Ethics committee reference number
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IR.HUMS.REC.1400.085
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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COVID-19
Primary outcomes
1
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Description
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Myalgia
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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to be or not to be
2
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Description
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fever
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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to be or not to be
3
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Description
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dry cough
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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to be or not to be
4
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Description
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Shortness of breath
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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to be or not to be
5
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Description
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Percentage of oxygen saturation
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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Oxygen meter
6
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Description
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WBC
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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Laboratory tests
7
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Description
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CRP
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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Laboratory tests
8
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Description
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MDA
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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Laboratory tests
9
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Description
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TAC
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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Laboratory tests
10
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Description
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Headache
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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to be or not to be
11
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Description
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mortality
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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number
12
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Description
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Neutrophil count
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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number
13
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Description
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Lymphocyte count
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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number
14
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Description
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The ratio of neutrophils to lymphocytes
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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Percentage
15
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Description
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25 hydroxyvitamin D
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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Nanograms per milliliter
16
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Description
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magnesium
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Timepoint
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at baseline and at the end of study (3 weeks later)
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Method of measurement
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milligram per deciliter
Intervention groups
1
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Description
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vitamin D supplement (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium supplement (300 mg/day).
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Category
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Treatment - Drugs
2
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Description
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vitamin D (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium placebo
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Category
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Treatment - Drugs
3
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Description
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Magnesium supplement (300 mg/day) and vitamin D placebo
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Category
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Treatment - Drugs
4
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Description
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Vitamin D placebo and magnesium placebo
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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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Bandare-abbas 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available