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 trial

Last registered on March 21, 2023
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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 trial
RCT ID
AEARCTR-0011109
Initial registration date
March 16, 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 21, 2023, 4:19 PM EDT

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

Locations

Country
Iraq
Region
kurdistan

Primary Investigator

Name
Hawal Lateef
Affiliation
Sulaimany polytechnic university
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Other Primary Investigator(s)

PI Name
Negin Kamari
PI Affiliation
Kermanshah university of medical sciences
Contact Investigator
PI Name
Shahab Rezayeian
PI Affiliation
Kermanshah university of medical sciences
Contact Investigator

Additional Trial Information

Status
In development
Start date
2023-01-02
End date
2023-03-31
Keywords
Health
Additional Keywords
BMI, Vitamin D, RCT
JEL code(s)
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, Hawal Lateef and Shahab Rezayeian. 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 trial." AEA RCT Registry. March 21. https://doi.org/10.1257/rct.11109-1.0
Sponsors & Partners

Sponsors

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
2023-01-05
Intervention End Date
2023-03-29

Primary Outcomes

Primary Outcomes (end points)
role BMI on Pfizer side effect
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
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.
Experimental Design Details
Randomization Method
Sample size will be calculated based on the previous study, with considering the proportion of fever ≥38 in normal weight as 9.8% and in obese people as 1.8%, study power of 80% and confidence level of 95%. Permuted block randomization method will be used to randomly assign patients in the study groups
Randomization Unit
clusters
Was the treatment clustered?
Yes

Experiment Characteristics

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

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

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