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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19 Respiratory Infection
• Intervention / Treatment: Combination product: Vitamin-D

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iraq
  • Sulaymaniyah, Iraq, 46001
    • Hawal Lateef Fateh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: Vitamin-D; The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.
Placebo Comparator: Placebo; The control group took a placebo prepared with the same shape and size of supplements.	Combination product: Vitamin-D; The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vit-D supplementation has role in improve IgG titer	Vitamin D supplement was given for 16 weeks	16 weeks

Collaborators and Investigators

• Sponsor: Sulaimany Polytechnic university
• Investigators: Principal Investigator: Hawal F Lateef, Msc, 1- Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): April 7, 2023

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: KTC20230105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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