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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D supplementation for 16 weeks | Experimental | The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks. |
|
| Placebo | Placebo Comparator | The control group took a placebo prepared with the same shape and size of supplements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin-D | Combination Product | The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect | Vitamin D supplement was given for 16 weeks | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vit-D supplementation has role in improve IgG titer | Vitamin D supplement was given for 16 weeks | 16 weeks |
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Inclusion criteria:
participants with COVID-19 positive tests.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hawal F Lateef, Msc | 1- Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawal Lateef Fateh | Sulaymaniyah | 46001 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37969936 | Derived | Fateh HL, Kareem G, Rezaeian S, Moludi J, Kamari N. The Effect of Vit-D Supplementation on the Side Effect of BioNTech, Pfizer Vaccination and Immunoglobulin G Response Against SARS-CoV-2 in the Individuals Tested Positive for COVID-19: A Randomized Control Trial. Clin Nutr Res. 2023 Oct 24;12(4):269-282. doi: 10.7762/cnr.2023.12.4.269. eCollection 2023 Oct. |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |