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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19 Pandemic, D Vitamin Deficiency, Antibody Hypersensitivity

Intervention / Treatment
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* Dietary Supplement: Vitamin D supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants using vitamin D supplements<br>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<br>* Only the experimental group (D) received the vitamin D supplement.<br>|
| No Intervention: Participants not using vitamin D supplements<br>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?
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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. | 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

| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Vaccine, Antibody, IgG, D vitamin, Nutrition