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

Last registered on March 17, 2023

Pre-Trial

Trial Information

General Information

Title
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
RCT ID
AEARCTR-0011075
Initial registration date
March 11, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 13, 2023, 3:32 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
March 17, 2023, 2:41 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
Sulaimany polytechnic university

Other Primary Investigator(s)

PI Affiliation
Sulaimany polytechnic university
PI Affiliation
Kermanshah univeristy of medical scinces
PI Affiliation
kermanshah university of medical scinces

Additional Trial Information

Status
In development
Start date
2023-01-02
End date
2023-03-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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.
External Link(s)

Registration Citation

Citation
Kamari, Negin et al. 2023. "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." AEA RCT Registry. March 17. https://doi.org/10.1257/rct.11075-2.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
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.
Intervention Start Date
2023-03-15
Intervention End Date
2023-03-20

Primary Outcomes

Primary Outcomes (end points)
Supplemntation have good effect on IgG
Primary Outcomes (explanation)
Role of anthropometric indices on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals with COVID-19

Secondary Outcomes

Secondary Outcomes (end points)
role of vit-d on Pfizer side effect
Secondary Outcomes (explanation)
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

Experimental Design

Experimental Design
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
Experimental Design Details
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.
Randomization Method
Public lottery
Randomization Unit
Group level randomization
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
500
Sample size: planned number of observations
250
Sample size (or number of clusters) by treatment arms
250
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
95%
IRB

Institutional Review Boards (IRBs)

IRB Name
Sulaimany polytechnic university
IRB Approval Date
2023-01-03
IRB Approval Number
KTC20230103
Analysis Plan

Analysis Plan Documents

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials