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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04476745
Other study ID # 2020-PHA-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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