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Role of Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05851313
Enrollment
500
Registered
2023-05-09
Start date
2022-12-05
Completion date
2023-04-07
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Respiratory Infection

Keywords

Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects

Brief 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. BMI has role in reduce BioNTech, Pfizer vaccine side effect 2. BMI has role in improve IgG titer 3. Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect 4. 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.

Interventions

COMBINATION_PRODUCTVitamin-D

The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.

Sponsors

Sulaimany Polytechnic university
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

participants with COVID-19 positive tests.

Exclusion criteria

1. Who did not take the vaccine 2. who take one dose of the vaccine 3. who did not come back for another dose 4. subjects who in the last 6 months received vitamin or mineral supplementation 5. those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

Design outcomes

Primary

MeasureTime frameDescription
Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect16 weeksVitamin D supplement was given for 16 weeks

Secondary

MeasureTime frameDescription
Vit-D supplementation has role in improve IgG titer16 weeksVitamin D supplement was given for 16 weeks

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026