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

September 26, 2022 updated by: Fatih Cesur, Ege University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61000
        • Avrasya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 23 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Participants using vitamin D supplements
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.
Dietary supplement: Vitamin D supplement
Only the experimental group (D) received the vitamin D supplement.
NO_INTERVENTION: Participants not using vitamin D supplements
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Within research completion, an average of 8 week
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
Within research completion, an average of 8 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Within research completion, an average of 8 week
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.
Within research completion, an average of 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avrasya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/02 (Avrasya University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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