Clinical trial NCT04476745: The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytokine Storm
Keywords: Covid -19
uninfected
IL-1
IL-6
TNF
VDD
Vitamin D3
50,000IU
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: IL-1 beta
timeFrame: 8 weeks
measure: IL-6
timeFrame: 8 weeks
measure: TNF
timeFrame: 8 weeks
Secondary outcomes:
measure: serum concentrations of 25-hydroxyvitamin D
timeFrame: 8 weeks
Other outcomes:
measure: lipid profile parameters
timeFrame: 8 weeks
Locations:
city: Amman
country: Jordan
facility: Mahmoud S Abu-Samak
Study officials:
affiliation: Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
name: Mahmoud S Abu-Samak, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
name: Dana A Bader, MSc
role: PRINCIPAL_INVESTIGATOR
References: