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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
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
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, 2:31 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

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 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
External Link(s)

Registration Citation

Citation
Kamari, Negin, Hawal Lateef and Hawal Lateef fateh. 2023. "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." AEA RCT Registry. March 17. https://doi.org/10.1257/rct.11075-1.1
Experimental Details

Interventions

Intervention(s)
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
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)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

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
Randomization Method
Public lottery
Randomization Unit
Group level randomization
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
400
Sample size: planned number of observations
200
Sample size (or number of clusters) by treatment arms
200
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
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