Back to resultsThe Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People
Primary Purpose
Cytokine Storm
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional prevention trial for Cytokine Storm focused on measuring Covid -19, uninfected, IL-1, IL-6, TNF, VDD, Vitamin D3, 50,000IU
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
Sites / Locations
- Mahmoud S Abu-Samak
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: VD3 group
Control group
Arm Description
Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,
Control group No intervention was given
Outcomes
Primary Outcome Measures
IL-1 beta
seum levels
IL-6
serum levels
TNF
serum levels
Secondary Outcome Measures
serum concentrations of 25-hydroxyvitamin D
ng/ml
Full Information
NCT ID
NCT04476745
First Posted
July 16, 2020
Last Updated
February 23, 2022
Sponsor
Applied Science Private University
1. Study Identification
Unique Protocol Identification Number
NCT04476745
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Applied Science Private University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytokine Storm
Keywords
Covid -19, uninfected, IL-1, IL-6, TNF, VDD, Vitamin D3, 50,000IU
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: VD3 group
Arm Type
Experimental
Arm Description
Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group No intervention was given
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
Primary Outcome Measure Information:
Title
IL-1 beta
Description
seum levels
Time Frame
8 weeks
Title
IL-6
Description
serum levels
Time Frame
8 weeks
Title
TNF
Description
serum levels
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
serum concentrations of 25-hydroxyvitamin D
Description
ng/ml
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
lipid profile parameters
Description
seum levels
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abu-Samak, PhD
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dana A Bader, MSc
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahmoud S Abu-Samak
City
Amman
Country
Jordan
12. IPD Sharing Statement
Learn more about this trial
The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People
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