The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People

NCT04476745 — Not applicable, Completed, 100 participants, Applied Science Private University

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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 Jordanian People With Vitamin D Deficiency

Registry	NCT04476745
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	100 (Actual)
Sponsor	Applied Science Private University (Other)
Conditions	Cytokine Storm
Interventions	Vitamin D3 (Dietary supplement)
Dates	start 2020-10-05, primary completion 2021-03-22, completion 2021-04-15, first posted 2020-07-20, last updated 2022-03-09
Locations	1 site in Jordan

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Experimental: VD3 group	Experimental	Dietary Supplement: Vitamin D3	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

Vitamin D3 (Dietary supplement), also known as cholecalciferol: Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks

+Outcome measures

Primary outcomes

IL-1 beta [8 weeks]: seum levels
IL-6 [8 weeks]: serum levels
TNF [8 weeks]: serum levels

Secondary outcomes

serum concentrations of 25-hydroxyvitamin D [8 weeks]: ng/ml

Other outcomes

lipid profile parameters [8 weeks]: seum levels

+Eligibility

Sex: All, ages: 30 Years to 66 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Mahmoud S Abu-Samak	Amman	Jordan

+Investigators

Mahmoud S Abu-Samak, PhD, Study chair, Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Dana A Bader, MSc, Principal investigator, Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

My Notes

Public

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