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

COVID-19 Pandemic Clinical Trial

— CoViD-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447065
• Other study ID #: 2021/02
• Secondary ID: 2021/02
• Status: Completed
• Phase: N/A
• Start date: May 7, 2022
• Est. completion date: July 7, 2022

Study information

• Verified date: September 2022
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 7, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 23 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avitaminosis
• COVID-19
• COVID-19 Pandemic
• D Vitamin Deficiency
• Hypersensitivity
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D supplement
Only the experimental group (D) received the vitamin D supplement.

Locations

Country	Name	City	State
Turkey	Avrasya University	Trabzon

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Avrasya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 COVID-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

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