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Field
Trial Title
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Before
Effect of Calcium and vit-D supplementation on the level of IgG and control of side effect of vaccination in Post covid-19 patient; a randomized control trials
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After
Role of anthropometric indices and long-term effect of vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals with COVID-19; Randomized control tria
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Abstract
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Before
A group of participants, all of whom were previously infected with the coronavirus, and now visited the hospital for vaccination, and we separated two groups, the first group to use nothing and the second group to use supplements. In the future, we will find differences between the two groups in terms of immunity and side effects to the vaccine
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After
A 3-day food record questionnaire (one day off and two days non-off) was taken from 2 groups at the beginning of the study. On the day patients were diagnosed as infected, they were asked to start taking supplements for 4 weeks and come back 4 weeks later for the first dose of vaccine. Patients were again asked to continue taking the supplement. Six to eight weeks after the first dose of vaccination, patients returned for a second dose of vaccine and were again asked to continue taking the supplement. 4 weeks after the second dose of vaccination, participants were asked to return for blood collection. Thus, participants continued to take the supplement for 14-16 weeks.
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Last Published
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Before
March 17, 2023 02:31 AM
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After
March 17, 2023 02:41 AM
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Intervention (Public)
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Before
A group of participants, all of whom were previously infected with the coronavirus, and now visited the hospital for vaccination, and we separated two groups, the first group to use nothing and the second group to use supplements. In the future, we will find differences between the two groups in terms of immunity and side effects to the vaccine
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After
The present study will be a multi-center, one-to-one randomized clinical trial. Inclusion criteria for selection of subjects will be a positive test for covid-19. Exclusion criteria included: 1. who dose not receive a vaccine or who have received one dose of vaccine and dose not return for the second dose, 2. patients with receiving any supplements in the last 6 months,
A 3-day food record questionnaire (one day off and two days non-off) will be take from 2 groups at the beginning of the study. On the day patients will diagnosed as infected, they will be asked to start taking supplements for 4 weeks and come back 4 weeks later for the first dose of vaccine. Patients will again asked to continue taking the supplement. Six to eight weeks after the first dose of vaccination, patients will returned for a second dose of vaccine and again asked to continue taking the supplement. 4 weeks after the second dose of vaccination, participants will asked to return for blood collection. Thus, participants continued to take the supplement for 14-16 weeks.
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Primary Outcomes (Explanation)
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Before
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After
Role of anthropometric indices on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals with COVID-19
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Planned Number of Clusters
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Before
400
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After
500
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Planned Number of Observations
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Before
200
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After
250
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Sample size (or number of clusters) by treatment arms
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Before
200
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After
250
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Power calculation: Minimum Detectable Effect Size for Main Outcomes
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Before
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After
95%
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Additional Keyword(s)
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Before
Vitamin, Calcium, covid-19
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After
Vitamin-D, covid-19, RCT
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Did you obtain IRB approval for this study?
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Before
No
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After
Yes
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Secondary Outcomes (End Points)
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Before
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After
role of vit-d on Pfizer side effect
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Secondary Outcomes (Explanation)
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Before
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After
Role of long-term effect of vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals with COVID-19
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