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Completed

NCT Number: NCT04476745

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

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

Other names: cholecalciferol

Primary outcomes

  1. IL-1 beta

    Time frame: 8 weeks

    seum levels

  2. IL-6

    Time frame: 8 weeks

    serum levels

  3. TNF

    Time frame: 8 weeks

    serum levels

Secondary outcomes

  1. serum concentrations of 25-hydroxyvitamin D

    Time frame: 8 weeks

    ng/ml

Other outcomes

  1. lipid profile parameters

    Time frame: 8 weeks

    seum levels

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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