search
Back to results

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

Primary Purpose

COVID-19 Respiratory Infection

Status
Completed
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
Vitamin-D
Sponsored by
Sulaimany Polytechnic university
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 Respiratory Infection focused on measuring Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: participants with COVID-19 positive tests. Exclusion criteria: Who did not take the vaccine who take one dose of the vaccine who did not come back for another dose subjects who in the last 6 months received vitamin or mineral supplementation those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

Sites / Locations

  • Hawal Lateef Fateh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D supplementation for 16 weeks

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
Vitamin D supplement was given for 16 weeks

Secondary Outcome Measures

Vit-D supplementation has role in improve IgG titer
Vitamin D supplement was given for 16 weeks

Full Information

First Posted
May 5, 2023
Last Updated
May 10, 2023
Sponsor
Sulaimany Polytechnic university
search

1. Study Identification

Unique Protocol Identification Number
NCT05851313
Brief Title
Role of Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response
Official Title
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; A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
April 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sulaimany Polytechnic university

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: BMI has role in reduce BioNTech, Pfizer vaccine side effect BMI has role in improve IgG titer Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect Vit-D supplementation has role in improve IgG titer
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection
Keywords
Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D supplementation for 16 weeks
Arm Type
Experimental
Arm Description
The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control group took a placebo prepared with the same shape and size of supplements.
Intervention Type
Combination Product
Intervention Name(s)
Vitamin-D
Intervention Description
The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.
Primary Outcome Measure Information:
Title
Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect
Description
Vitamin D supplement was given for 16 weeks
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Vit-D supplementation has role in improve IgG titer
Description
Vitamin D supplement was given for 16 weeks
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: participants with COVID-19 positive tests. Exclusion criteria: Who did not take the vaccine who take one dose of the vaccine who did not come back for another dose subjects who in the last 6 months received vitamin or mineral supplementation those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hawal F Lateef, Msc
Organizational Affiliation
1- Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawal Lateef Fateh
City
Sulaymaniyah
ZIP/Postal Code
46001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs