Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Enrolling by invitation
First Posted : July 20, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Suleiman Abu-Samak, Applied Science Private University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Jordan
Mahmoud S Abu-Samak
Amman, Jordan
Sponsors and Collaborators
Applied Science Private University
Investigators
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: December 8, 2020
Last Verified: December 2020

Layout table for additional information
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:
Layout table for MeSH terms
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
 Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents