Cytokine StormNCT04476745
The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People
A study testing Vitamin D3 in people with Cytokine Storm, run by Applied Science Private University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytokine Storm
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 5 Oct 2020to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cytokine Storm
- Being tested
- Vitamin D3
- Keywords
- Covid -19, uninfected, IL-1, IL-6, TNF, VDD, Vitamin D3, 50,000IU
- Medical subject headings
- Cytokine Release Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental: VD3 group | Experimental | Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol, Receives: Dietary Supplement: Vitamin D3 |
| Control group | No intervention | Control group No intervention was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1 beta
seum levels
Measured: 8 weeks
IL-6
serum levels
Measured: 8 weeks
TNF
serum levels
Measured: 8 weeks
Secondary outcomes (1)
serum concentrations of 25-hydroxyvitamin D
ng/ml
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start5 Oct 2020
- Primary completion22 Mar 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine StormStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Suleiman Abu-Samak, Applied Science Private University
- Investigators
- Mahmoud S Abu-Samak, PhD, Study chair, Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -JordanDana A Bader, MSc, Principal investigator, Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476745
- Sponsor's protocol ID
- 2020-PHA-16
- Status last verified
- Feb 2022
- First submitted
- 16 Jul 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04476745
- Acronym / sponsor ID
- 2020-PHA-16
- Conditions
- Cytokine Storm
- Keywords
- Covid -19, uninfected, IL-1, IL-6, TNF, VDD, Vitamin D3, 50,000IU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: VD3 group | Experimental | Dietary Supplement: Vitamin D3Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol, |
| Control group | No intervention | –Control group No intervention was given |
Who may qualify
- Ages
- 30 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferolDietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks | Dietary supplement | Experimental: VD3 group |
Primary outcome
IL-1 beta
Time frame: 8 weeks
seum levels
IL-6
Time frame: 8 weeks
serum levels
TNF
Time frame: 8 weeks
serum levels
1 secondary outcome
serum concentrations of 25-hydroxyvitamin D
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud S Abu-Samak, PhD study chair
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Dana A Bader, MSc principal investigator
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Cytokine Storm, run by Applied Science Private University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-1 beta (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.