- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05447065
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- 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
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Trabzon, Turkey, 61000
- Avrasya University
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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
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 |
Intervention / Treatment |
---|---|
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.
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Only the experimental group (D) received the vitamin D supplement.
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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.
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What is the study measuring?
Primary Outcome Measures
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
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Within research completion, an average of 8 week
|
Secondary Outcome Measures
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.
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Within research completion, an average of 8 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
May 7, 2022
Primary Completion (ACTUAL)
June 10, 2022
Study Completion (ACTUAL)
July 7, 2022
Study Registration Dates
First Submitted
July 5, 2022
First Submitted That Met QC Criteria
July 5, 2022
First Posted (ACTUAL)
July 7, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 26, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Nutrition Disorders
- Deficiency Diseases
- Malnutrition
- COVID-19
- Hypersensitivity
- Vitamin D Deficiency
- Avitaminosis
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Vitamin D
Other Study ID 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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