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OpenTrials
Completed

NCT Number: NCT05851313

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

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

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hawal Lateef Fateh

Sulaymaniyah, 46001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

participants with COVID-19 positive tests.

Exclusion criteria

  • 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.

Treatment and study plan

Vitamin-D

Combination Product

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

Primary outcomes

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

    Time frame: 16 weeks

    Vitamin D supplement was given for 16 weeks

Secondary outcomes

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

    Time frame: 16 weeks

    Vitamin D supplement was given for 16 weeks

Sponsors and collaborators

Lead sponsor

Sulaimani Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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