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CompletedNCT05851313Updated May 12, 2023

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

A Phase 3 interventional study of Vitamin-D in COVID-19 Respiratory Infection, sponsored by Sulaimany Polytechnic university. Completed at 1 site in Iraq. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Sulaimany Polytechnic university · Phase 3, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was Feb 2023, 3 years 7 months ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled Dec 2022, registered May 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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
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.

02

Conditions studied

  • COVID-19 Respiratory Infection

Keywords

  • Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 500 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Sulaimany Polytechnic university is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

participants with COVID-19 positive tests.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    Vitamin D supplementation for 16 weeks

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

    Combination Product: Vitamin-D

  • Placebo comparator
    Placebo

    The control group took a placebo prepared with the same shape and size of supplements.

    Combination Product: Vitamin-D

Interventions

  • Combination productVitamin-D

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

06

What researchers measure

Primary outcomes

  1. Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect

    Vitamin D supplement was given for 16 weeks

    Time frame: 16 weeks

Secondary outcomes

  1. Vit-D supplementation has role in improve IgG titer

    Vitamin D supplement was given for 16 weeks

    Time frame: 16 weeks

07

Study locations

1 site
  • Hawal Lateef Fateh
    Sulaymaniyah, 46001, Iraq
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851313
Lead sponsor
Sulaimany Polytechnic university
Responsible party
Hawal Lateef Fateh (Dr Hawal Lateef Fateh, Sulaimany Polytechnic university) — Principal investigator
First posted
May 9, 2023
Start date
Dec 5, 2022
Primary completion
Feb 10, 2023
Completion
Apr 7, 2023
Last update
May 12, 2023

Study contacts

Hawal F Lateef, Msc
principal investigator · 1- Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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