Role of Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response

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

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2023-04-07

Brief Summary

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The goal of this clinical trial study is to investigate the role of anthropometric indices and Vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G response against SARS-CoV-2 in individuals infected with COVID-19.

The main question\[s\] it aims to answer are:

1. BMI has role in reduce BioNTech, Pfizer vaccine side effect
2. BMI has role in improve IgG titer
3. Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
4. Vit-D supplementation has role in improve IgG titer

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Detailed Description

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The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast, for 14-16 weeks. The control group took a placebo prepared with the same shape and size of supplements. The supplement was given to the patients by someone other than the researcher, to ensure that the researchers did not know which group receiving the supplement/placebo (given the double-blindness of the study). Also, in this study, the person who did the data analysis did not aware of randomization. at first, a 3-day recall food questionnaire was taken from two groups. From the day, the subjects tested positive, they were asked to start supplementation for 4 weeks and return after that to take the first dose of the vaccine. Subjects were asked to continue to use supplements after the first vaccination. After 6 to 8 weeks, patients came back for another vaccination dose and were again asked to use the supplement for 4 weeks again, after that subjects were asked to come for a blood test.

Conditions

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COVID-19 Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D supplementation for 16 weeks

The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.

Group Type EXPERIMENTAL

Vitamin-D

Intervention Type COMBINATION_PRODUCT

The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.

Placebo

The control group took a placebo prepared with the same shape and size of supplements.

Group Type PLACEBO_COMPARATOR

Vitamin-D

Intervention Type COMBINATION_PRODUCT

The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.

Interventions

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Vitamin-D

The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

participants with COVID-19 positive tests.

Exclusion Criteria

1. Who did not take the vaccine
2. who take one dose of the vaccine
3. who did not come back for another dose
4. subjects who in the last 6 months received vitamin or mineral supplementation
5. those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes