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Impact of Vitamin D Supplementation on COVID-19 Vaccine Response and IgG Antibodies in Deficient Women. (CoVıD-19)

Primary Purpose

COVID-19 Pandemic, D Vitamin Deficiency, Antibody Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vitamin D supplement
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 Pandemic focused on measuring COVID-19 Vaccine, Antibody, IgG, D vitamin, Nutrition

Eligibility Criteria

19 Years - 23 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • The study consisted of young volunteer women who completed 2 doses of COVID-19 vaccines, did not receive the 3rd dose, and spent an average of 65 days over the 2nd dose. Participants were included in the study when IgM value was negative, IgG value was positive, they were not older than 25 years, and serum 25-Hydroxy (25(OH)) vitamin D was below 30 ng/mL.

Exclusion Criteria:

  • In addition, individuals participating in the research who were pregnant, had physician-diagnosed cardiovascular diseases, had kidney or liver failure, and had the chronic obstructive pulmonary disease were not included in the study.

Sites / Locations

  • Avrasya University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Participants using vitamin D supplements

Participants not using vitamin D supplements

Arm Description

Participants in the experimental group were given 150,000 IU (10 ml) of vitamin D3 supplementation, and it was used regularly for 2 months. From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 measurements were taken from the participants.

No supplement was given to the control group. From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 measurements were taken from the participants.

Outcomes

Primary Outcome Measures

From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 blood measurements were taken from the participants. Antibody levels were measured with the fluorescent immunological (FIA) method.
Compared to other coronaviruses, it was understood that there is an instant need for a vaccine to prevent SARS CoV-2 because of its faster transmission. However, it is very important to determine that the COVID-19 vaccine is immune to individuals, and it has been emphasized that Immunoglobulin G (IgG) levels are checked for immune testing and it is important that these levels are high. People's immune systems or nutritional levels are influential in the high rate or efficiency of immunoglobin levels Studies have reported that individuals with adequate and balanced nutrition have a stronger immune system

Secondary Outcome Measures

From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 blood measurements were taken from the participants. 25(OH) Vitamin D level levels were measured with the fluorescent immunological (FIA) method.
Since a treatment process is not clear at the beginning of the COVID-19 disease, these supplements, such as vitamin D, C, and B vitamin groups and zinc minerals, have been given to COVID-19 patients in the clinic. In addition, 25-Hydroxy(25(OH)) vitamin D deficiency is a common condition for these patients. Accordingly, skeletal system diseases, immune system diseases, inflammatory bowel diseases, respiratory tract infections, viral infections, etc. affect situations are also seen. The pathogenesis relationship of 25(OH) vitamin D with the COVID-19 pandemic is consistently seen in the clinical data. In addition, 25(OH) vitamin D deficiency has a negative effect on people with COVID-19. For this reason, it is thought that hospitalizations due to COVİD-19 are increasing In a way, it is claimed to be an important factor in the severe course of the disease.

Full Information

First Posted
July 5, 2022
Last Updated
September 26, 2022
Sponsor
Ege University
Collaborators
Avrasya University
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1. Study Identification

Unique Protocol Identification Number
NCT05447065
Brief Title
Impact of Vitamin D Supplementation on COVID-19 Vaccine Response and IgG Antibodies in Deficient Women.
Acronym
CoVıD-19
Official Title
Impact of Vitamin D Supplementation on COVID-19 Vaccine Response and IgG Antibodies in Deficient Women.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 7, 2022 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
July 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
Collaborators
Avrasya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Decreased immunity in individuals causes a decrease in vaccine response, and vitamin D worsens this course. Vitamin D is thought to be a vitamin that can strengthen the innate immune response, inhibit the adaptive system, and modulate the vaccine response. The effect of vitamin D intake on antibodies was studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic, D Vitamin Deficiency, Antibody Hypersensitivity
Keywords
COVID-19 Vaccine, Antibody, IgG, D vitamin, Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants using vitamin D supplements
Arm Type
Experimental
Arm Description
Participants in the experimental group were given 150,000 IU (10 ml) of vitamin D3 supplementation, and it was used regularly for 2 months. From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 measurements were taken from the participants.
Arm Title
Participants not using vitamin D supplements
Arm Type
No Intervention
Arm Description
No supplement was given to the control group. From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 measurements were taken from the participants.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplement
Intervention Description
Only the experimental group (D) received the vitamin D supplement.
Primary Outcome Measure Information:
Title
From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 blood measurements were taken from the participants. Antibody levels were measured with the fluorescent immunological (FIA) method.
Description
Compared to other coronaviruses, it was understood that there is an instant need for a vaccine to prevent SARS CoV-2 because of its faster transmission. However, it is very important to determine that the COVID-19 vaccine is immune to individuals, and it has been emphasized that Immunoglobulin G (IgG) levels are checked for immune testing and it is important that these levels are high. People's immune systems or nutritional levels are influential in the high rate or efficiency of immunoglobin levels Studies have reported that individuals with adequate and balanced nutrition have a stronger immune system
Time Frame
Within research completion, an average of 8 week
Secondary Outcome Measure Information:
Title
From the first measurement, 2 more measurements were taken, 28 days apart, and a total of 3 blood measurements were taken from the participants. 25(OH) Vitamin D level levels were measured with the fluorescent immunological (FIA) method.
Description
Since a treatment process is not clear at the beginning of the COVID-19 disease, these supplements, such as vitamin D, C, and B vitamin groups and zinc minerals, have been given to COVID-19 patients in the clinic. In addition, 25-Hydroxy(25(OH)) vitamin D deficiency is a common condition for these patients. Accordingly, skeletal system diseases, immune system diseases, inflammatory bowel diseases, respiratory tract infections, viral infections, etc. affect situations are also seen. The pathogenesis relationship of 25(OH) vitamin D with the COVID-19 pandemic is consistently seen in the clinical data. In addition, 25(OH) vitamin D deficiency has a negative effect on people with COVID-19. For this reason, it is thought that hospitalizations due to COVİD-19 are increasing In a way, it is claimed to be an important factor in the severe course of the disease.
Time Frame
Within research completion, an average of 8 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The study consisted of young volunteer women who completed 2 doses of COVID-19 vaccines, did not receive the 3rd dose, and spent an average of 65 days over the 2nd dose. Participants were included in the study when IgM value was negative, IgG value was positive, they were not older than 25 years, and serum 25-Hydroxy (25(OH)) vitamin D was below 30 ng/mL. Exclusion Criteria: In addition, individuals participating in the research who were pregnant, had physician-diagnosed cardiovascular diseases, had kidney or liver failure, and had the chronic obstructive pulmonary disease were not included in the study.
Facility Information:
Facility Name
Avrasya University
City
Trabzon
ZIP/Postal Code
61000
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://doi.org/10.3389/fimmu.2019.00065
Description
Related Info
URL
https://doi.org/10.3390/biomedicines9111714
Description
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URL
https://doi.org/10.1016/J.RETRAM.2022.103344
Description
Related Info
URL
https://doi.org/10.1093/AJCN/77.1.204
Description
Related Info
URL
https://doi.org/10.1016/j.jsbmb.2021.105964
Description
Related Info

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Impact of Vitamin D Supplementation on COVID-19 Vaccine Response and IgG Antibodies in Deficient Women.

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