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

NCT ID: NCT05447065

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-07

Study Completion Date

2022-07-07

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.

Detailed Description

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Conditions

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COVID-19 Pandemic D Vitamin Deficiency Antibody Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Vitamin D supplement

Intervention Type DIETARY_SUPPLEMENT

Only the experimental group (D) received the vitamin D supplement.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D supplement

Only the experimental group (D) received the vitamin D supplement.

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Avrasya University

OTHER

Sponsor Role collaborator

Ege University

OTHER

Sponsor Role lead

Responsible Party

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Fatih Cesur

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Avrasya University

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cesur F, Atasever Z, Ozoran Y. Impact of vitamin D3 supplementation on COVID-19 vaccine response and immunoglobulin G antibodies in deficient women: A randomized controlled trial. Vaccine. 2023 Apr 24;41(17):2860-2867. doi: 10.1016/j.vaccine.2023.03.046. Epub 2023 Mar 27.

Reference Type DERIVED
PMID: 37003908 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2021/02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021/02

Identifier Type: -

Identifier Source: org_study_id

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