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

• Sponsor: Sulaimany Polytechnic university (Other)
• Overall Status: Completed
• CT.gov ID: NCT05851313
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 123.7

Study Details

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:

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection	Combination Product: Vitamin-D	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Dec 5, 2022
• Actual Primary Completion Date: Feb 10, 2023
• Actual Study Completion Date: Apr 7, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect [16 weeks]

   Vitamin D supplement was given for 16 weeks

Secondary Outcome Measures

1. Vit-D supplementation has role in improve IgG titer [16 weeks]

   Vitamin D supplement was given for 16 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hawal Lateef Fateh	Sulaymaniyah		Iraq	46001

Sponsors and Collaborators

• Sulaimany Polytechnic university

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hawal Lateef Fateh, Dr Hawal Lateef Fateh, Sulaimany Polytechnic university
• ClinicalTrials.gov Identifier: NCT05851313
• Other Study ID Numbers: KTC20230105
• First Posted: May 9, 2023
• Last Update Posted: May 12, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Hawal Lateef Fateh, Dr Hawal Lateef Fateh, Sulaimany Polytechnic university: Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects
• Additional relevant MeSH terms: COVID-19; Respiratory Tract Infections; Vitamin D

Study Results

No Results Posted as of May 12, 2023