The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People
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ClinicalTrials.gov Identifier: NCT04476745 |
Recruitment Status :
Completed
First Posted : July 20, 2020
Last Update Posted : March 9, 2022
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Condition or disease | Intervention/treatment | Phase |
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Cytokine Storm | Dietary Supplement: Vitamin D3 | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | October 5, 2020 |
Actual Primary Completion Date : | March 22, 2021 |
Actual Study Completion Date : | April 15, 2021 |

Arm | Intervention/treatment |
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Experimental: Experimental: VD3 group
Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,
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Dietary Supplement: Vitamin D3
Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
Other Name: cholecalciferol |
No Intervention: Control group
Control group No intervention was given
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- IL-1 beta [ Time Frame: 8 weeks ]seum levels
- IL-6 [ Time Frame: 8 weeks ]serum levels
- TNF [ Time Frame: 8 weeks ]serum levels
- serum concentrations of 25-hydroxyvitamin D [ Time Frame: 8 weeks ]ng/ml
- lipid profile parameters [ Time Frame: 8 weeks ]seum levels

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Ages Eligible for Study: | 30 Years to 66 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476745
Jordan | |
Mahmoud S Abu-Samak | |
Amman, Jordan |
Study Chair: | Mahmoud S Abu-Samak, PhD | Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan | |
Principal Investigator: | Dana A Bader, MSc | Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan |
Responsible Party: | Mahmoud Suleiman Abu-Samak, Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics, Applied Science Private University |
ClinicalTrials.gov Identifier: | NCT04476745 |
Other Study ID Numbers: |
2020-PHA-16 |
First Posted: | July 20, 2020 Key Record Dates |
Last Update Posted: | March 9, 2022 |
Last Verified: | February 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Covid -19 uninfected IL-1 IL-6 |
TNF VDD Vitamin D3 50,000IU |
Cytokine Release Syndrome Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Shock Vitamin D |
Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |