Hawal Lateef Fateh
Sulaymaniyah, 46001, Iraq
NCT Number: NCT05851313
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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Notify Me30 year–75 year
All sexes
Interventional
Phase 3
Sulaymaniyah, 46001, Iraq
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.
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
The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.
Time frame: 16 weeks
Vitamin D supplement was given for 16 weeks
Time frame: 16 weeks
Vitamin D supplement was given for 16 weeks
Sulaimani Polytechnic University
Other
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
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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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