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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04476745
Recruitment Status : Completed
First Posted : July 20, 2020
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Mahmoud Suleiman Abu-Samak, Applied Science Private University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cytokine Storm Dietary Supplement: Vitamin D3 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : October 5, 2020
Actual Primary Completion Date : March 22, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: VD3 group
Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,
 Dietary Supplement: Vitamin D3
Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
Other Name: cholecalciferol
No Intervention: Control group
Control group No intervention was given


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. serum concentrations of 25-hydroxyvitamin D [ Time Frame: 8 weeks ]
    ng/ml


Other Outcome Measures:
  1. lipid profile parameters [ Time Frame: 8 weeks ]
    seum levels


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476745


Locations
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Jordan
Mahmoud S Abu-Samak
Amman, Jordan
Sponsors and Collaborators
Applied Science Private University
Investigators
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Study Chair: Mahmoud S Abu-Samak, PhD Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Principal Investigator: Dana A Bader, MSc Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
More Information
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Responsible Party: Mahmoud Suleiman Abu-Samak, Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics, Applied Science Private University
ClinicalTrials.gov Identifier: NCT04476745    
Other Study ID Numbers: 2020-PHA-16
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Suleiman Abu-Samak, Applied Science Private University:
Covid -19
uninfected
IL-1
IL-6
 TNF
VDD
Vitamin D3
50,000IU
Additional relevant MeSH terms:
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Cytokine Release Syndrome
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Vitamin D
 Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents