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

Cytokine Storm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476745
• Other study ID #: 2020-PHA-16
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: February 2022
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 15, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytokine Release Syndrome
• Cytokine Storm

Intervention

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

Locations

Country	Name	City	State
Jordan	Mahmoud S Abu-Samak	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lipid profile parameters	seum levels	8 weeks
Primary	IL-1 beta	seum levels	8 weeks
Primary	IL-6	serum levels	8 weeks
Primary	TNF	serum levels	8 weeks
Secondary	serum concentrations of 25-hydroxyvitamin D	ng/ml	8 weeks