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 Jordanian People With Vitamin D Deficiency
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedStudy Start
First participant enrolled
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2021
CompletedMarch 9, 2022
February 1, 2022
6 months
July 16, 2020
February 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
IL-1 beta
seum levels
8 weeks
IL-6
serum levels
8 weeks
TNF
serum levels
8 weeks
Secondary Outcomes (1)
serum concentrations of 25-hydroxyvitamin D
8 weeks
Other Outcomes (1)
lipid profile parameters
8 weeks
Study Arms (2)
Experimental: VD3 group
EXPERIMENTALDietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,
Control group
NO INTERVENTIONControl group No intervention was given
Interventions
Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mahmoud S Abu-Samak
Amman, Jordan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics
Study Record Dates
First Submitted
July 16, 2020
First Posted
July 20, 2020
Study Start
October 5, 2020
Primary Completion
March 22, 2021
Study Completion
April 15, 2021
Last Updated
March 9, 2022
Record last verified: 2022-02