CClinicalTrials.gg
CompletedNCT04476745Updated Mar 9, 2022

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

An interventional study of Vitamin D3 in Cytokine Storm, sponsored by Applied Science Private University. Completed at 1 site in Jordan. Open to participants aged 30 Years to 66 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by Applied Science Private University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
30 Years to 66 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cytokine Storm

Keywords

  • Covid -19
  • uninfected
  • IL-1
  • IL-6
  • TNF
  • VDD
  • Vitamin D3
  • 50,000IU
03

In context

Cytokine Release Syndrome

133 studies on the registry are indexed under Cytokine Release Syndrome; 29 are open to participants now.

This study's enrollment of 100 is above the median of 48 across 95 interventional studies indexed under Cytokine Release Syndrome.

Browse Cytokine Release Syndrome studies →

Lead sponsor

Applied Science Private University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 66 Years
Sexes eligible
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

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Experimental: VD3 group

    Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,

    Dietary Supplement: Vitamin D3

  • No intervention
    Control group

    Control group No intervention was given

Interventions

  • Dietary supplementVitamin D3

    Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks

    Also known as: cholecalciferol

06

What researchers measure

Primary outcomes

  1. IL-1 beta

    seum levels

    Time frame: 8 weeks

  2. IL-6

    serum levels

    Time frame: 8 weeks

  3. TNF

    serum levels

    Time frame: 8 weeks

Secondary outcomes

  1. serum concentrations of 25-hydroxyvitamin D

    ng/ml

    Time frame: 8 weeks

Other outcomes

  1. lipid profile parameters

    seum levels

    Time frame: 8 weeks

07

Study locations

1 site
  • Mahmoud S Abu-Samak
    Amman, Jordan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04476745
Lead sponsor
Applied Science Private University
Responsible party
Mahmoud Suleiman Abu-Samak (Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics, Applied Science Private University) — Principal investigator
First posted
Jul 20, 2020
Start date
Oct 5, 2020
Primary completion
Mar 22, 2021
Completion
Apr 15, 2021
Last update
Mar 9, 2022

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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