COVID-19 Respiratory InfectionPhase 3NCT05851313
Role of Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response
A Phase 3 study testing Vitamin-D in people with COVID-19 Respiratory Infection, run by Sulaimani Polytechnic University at 1 site in Iraq.
Trial summary
The goal of this clinical trial study is to investigate the role of anthropometric indices and Vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals infected with COVID-19. The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- Vitamin-D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteIraq
- Study dates
- 5 Dec 2022to 7 Apr 2023
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants with COVID-19 positive tests.
Who cannot join
- Who did not take the vaccine
- who take one dose of the vaccine
- who did not come back for another dose
- subjects who in the last 6 months received vitamin or mineral supplementation
- those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Anthropometric Indices and Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response Against SARS-CoV-2 in Individuals Infected With COVID-19; A Randomized Control Trial
The goal of this clinical trial study is to investigate the role of anthropometric indices and Vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals infected with COVID-19.
The main question[s] it aims to answer are:
- BMI has role in reduce BioNTech, Pfizer vaccine side effect
- BMI has role in improve IgG titer
- Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
- Vit-D supplementation has role in improve IgG titer
Read the detailed description
The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast, for 14-16 weeks. The control group took a placebo prepared with the same shape and size of supplements. The supplement was given to the patients by someone other than the researcher, to ensure that the researchers did not know which group receiving the supplement/placebo (given the double-blindness of the study). Also, in this study, the person who did the data analysis did not aware of randomization. at first, a 3-day recall food questionnaire was taken from two groups. From the day, the subjects tested positive, they were asked to start supplementation for 4 weeks and return after that to take the first dose of the vaccine. Subjects were asked to continue to use supplements after the first vaccination. After 6 to 8 weeks, patients came back for another vaccination dose and were again asked to use the supplement for 4 weeks again, after that subjects were asked to come for a blood test.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- Vitamin-D
- Keywords
- Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin-DCombination product
The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation for 16 weeks | Experimental | The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks. Receives: Combination Product: Vitamin-D |
| Placebo | Placebo comparator | The control group took a placebo prepared with the same shape and size of supplements. Receives: Combination Product: Vitamin-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
Vitamin D supplement was given for 16 weeks
Measured: 16 weeks
Secondary outcomes (1)
Vit-D supplementation has role in improve IgG titer
Vitamin D supplement was given for 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start5 Dec 2022
- Primary completion10 Feb 2023
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Respiratory InfectionStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sulaimani Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hawal Lateef Fateh, Sulaimani Polytechnic University
- Investigators
- Hawal F Lateef, Msc, Principal investigator, 1- Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851313
- Sponsor's protocol ID
- KTC20230105
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fateh HL, Kareem G, Rezaeian S, Moludi J, Kamari N. The Effect of Vit-D Supplementation on the Side Effect of BioNTech, Pfizer Vaccination and Immunoglobulin G Response Against SARS-CoV-2 in the Individuals Tested Positive for COVID-19: A Randomized Control Trial. Clin Nutr Res. 2023 Oct 24;12(4):269-282. doi: 10.7762/cnr.2023.12.4.269. eCollection 2023 Oct.
PubMed 37969936
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anthropometric Indices and Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response Against SARS-CoV-2 in Individuals Infected With COVID-19; A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05851313
- Acronym / sponsor ID
- KTC20230105
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sulaimani Polytechnic UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 9 May 2023 (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 goal of this clinical trial study is to investigate the role of anthropometric indices and Vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals infected with COVID-19.
The main question[s] it aims to answer are:
- BMI has role in reduce BioNTech, Pfizer vaccine side effect
- BMI has role in improve IgG titer
- Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
- Vit-D supplementation has role in improve IgG titer
Detailed description
The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast, for 14-16 weeks. The control group took a placebo prepared with the same shape and size of supplements. The supplement was given to the patients by someone other than the researcher, to ensure that the researchers did not know which group receiving the supplement/placebo (given the double-blindness of the study). Also, in this study, the person who did the data analysis did not aware of randomization. at first, a 3-day recall food questionnaire was taken from two groups. From the day, the subjects tested positive, they were asked to start supplementation for 4 weeks and return after that to take the first dose of the vaccine. Subjects were asked to continue to use supplements after the first vaccination. After 6 to 8 weeks, patients came back for another vaccination dose and were again asked to use the supplement for 4 weeks again, after that subjects were asked to come for a blood test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation for 16 weeks | Experimental | Combination Product: Vitamin-DThe intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks. |
| Placebo | Placebo comparator | Combination Product: Vitamin-DThe control group took a placebo prepared with the same shape and size of supplements. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants with COVID-19 positive tests.
Key exclusion criteria (5 listed)
- Who did not take the vaccine
- who take one dose of the vaccine
- who did not come back for another dose
- subjects who in the last 6 months received vitamin or mineral supplementation
- those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.
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-DThe intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks. | Combination product | Placebo, Vitamin D supplementation for 16 weeks |
Primary outcome
Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
Time frame: 16 weeks
Vitamin D supplement was given for 16 weeks
1 secondary outcome
Vit-D supplementation has role in improve IgG titer
Time frame: 16 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 12 May 2023.
- Derived from this study: PubMed 37969936Fateh HL, Kareem G, Rezaeian S, Moludi J, Kamari N. The Effect of Vit-D Supplementation on the Side Effect of BioNTech, Pfizer Vaccination and Immunoglobulin G Response Against SARS-CoV-2 in the Individuals Tested Positive for COVID-19: A Randomized Control Trial. Clin Nutr Res. 2023 Oct 24;12(4):269-282. doi: 10.7762/cnr.2023.12.4.269. eCollection 2023 Oct.
- Individual participant dataSharing planned: No
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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.
Hawal F Lateef, Msc principal investigator
1- Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin-D in people with COVID-19 Respiratory Infection, run by Sulaimani Polytechnic University at 1 site in Iraq.
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 5 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 12 May 2023. 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 Iraq. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851313, which also lists 1 linked publication.
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 12 May 2023.