NCT05447065

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

July 5, 2022

Last Update Submit

September 26, 2022

Conditions

COVID-19 PandemicD Vitamin DeficiencyAntibody Hypersensitivity

Keywords

COVID-19 VaccineAntibodyIgGD vitaminNutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    Within research completion, an average of 8 week

Study Arms (2)

Participants using vitamin D supplements

EXPERIMENTAL

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

Participants not using vitamin D supplements

NO INTERVENTION

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.

Interventions

Vitamin D supplementDIETARY_SUPPLEMENT

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

Participants using vitamin D supplements

Eligibility Criteria

Age19 Years - 23 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avrasya University

Trabzon, 61000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 37003908DERIVED

Related Links

MeSH Terms

Conditions

COVID-19Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 7, 2022

Study Start

May 7, 2022

Primary Completion

June 10, 2022

Study Completion

July 7, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations

TU(1)