Role of Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response
- Conditions
- COVID-19 Respiratory Infection
- Interventions
- Combination Product: Vitamin-D
- Registration Number
- NCT05851313
- Lead Sponsor
- Sulaimany Polytechnic university
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D supplementation for 16 weeks Vitamin-D The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks. Placebo Vitamin-D The control group took a placebo prepared with the same shape and size of supplements.
- Primary Outcome Measures
Name Time Method Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect 16 weeks Vitamin D supplement was given for 16 weeks
- Secondary Outcome Measures
Name Time Method Vit-D supplementation has role in improve IgG titer 16 weeks Vitamin D supplement was given for 16 weeks
Trial Locations
- Locations (1)
Hawal Lateef Fateh
🇮🇶Sulaymaniyah, Iraq