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The effect of Weekly 50,000 IU vitamin D3 supplements on the serum levels of selected cytokines involved in cytokine storm of Covid-19; A randomized clinical trial in the Covid-19 uninfected people with vitamin D deficiency.
No data are available on the effect of Weekly 50,000 IU vitamin D3 supplements on the serum levels of selected cytokines involved in cytokine storm of Covid-19 in the Covid-19 uninfected Jordanian people with vitamin D deficiency. This study was designed to investigate whether a high dose of vitamin D3 (50,000 IU) / week for 8 weeks supplementation has a potential effect on cytokine storm of Covid-19; such as IL-1 beta, IL-6, and TNF in the Covid-19 uninfected Jordanian people with vitamin D deficiency.
This study aims to assess whether high doses of vitamin D3 may improve immune responses against COVID-19 infection in uninfected Jordanian peoples. We hypothesize that Weekly 50,000 IU vitamin D3 supplements will significantly change immune responses compared with the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: VD3 group | Experimental | Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol, |
|
| Control group | No Intervention | Control group No intervention was given |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| IL-1 beta | seum levels | 8 weeks |
| IL-6 | serum levels | 8 weeks |
| TNF | serum levels | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| serum concentrations of 25-hydroxyvitamin D | ng/ml | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| lipid profile parameters | seum levels | 8 weeks |
Inclusion Criteria:
Age ≥30 years old Male and female Jordanian ASU students and employees who live in Amman. Informed written consent from the participant prior to the start of the study. a serum 25(OH)D concentration less than 30 ng/mL.
Exclusion Criteria:
Any eligible subject refuses to apply with informed written consent before the start of the study. Men or women previously diagnosed with chronic diseases, including kidney disease or GIT problems. Who are receiving vitamin D3 supplements (3 months before the start of the study). Pregnant, Breastfeeding females, Females using hormonal contraceptives
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud S Abu-Samak, PhD | Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan | Study Chair |
| Dana A Bader, MSc | Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahmoud S Abu-Samak | Amman | Jordan |
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| ID | Term |
|---|---|
| D000080424 | Cytokine Release Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| D012769 | Shock |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |