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

NCT05851313 | Completed Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: KTC20230105
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Respiratory Infection

Keywords

Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects

Outcome Measures

Primary Outcomes (1)

• Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect

  Vitamin D supplement was given for 16 weeks

  16 weeks

Secondary Outcomes (1)

• Vit-D supplementation has role in improve IgG titer

  16 weeks

Study Arms (2)

Vitamin D supplementation for 16 weeks

EXPERIMENTAL

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

Combination Product: Vitamin-D

Placebo

PLACEBO COMPARATOR

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

Combination Product: Vitamin-D

Interventions

Vitamin-D COMBINATION_PRODUCT

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

Placebo; Vitamin D supplementation for 16 weeks

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants with COVID-19 positive tests.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sulaimany Polytechnic university: lead

Study Sites (1)

Hawal Lateef Fateh

Sulaymaniyah, 46001, Iraq

Location

Related Publications (1)

• Fateh HL, Kareem G, Rezaeian S, Moludi J, Kamari N. The Effect of Vit-D Supplementation on the Side Effect of BioNTech, Pfizer Vaccination and Immunoglobulin G Response Against SARS-CoV-2 in the Individuals Tested Positive for COVID-19: A Randomized Control Trial. Clin Nutr Res. 2023 Oct 24;12(4):269-282. doi: 10.7762/cnr.2023.12.4.269. eCollection 2023 Oct.

  PMID: 37969936 DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Hawal F Lateef, Msc

  1- Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Hawal Lateef Fateh

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 9, 2023
• Study Start: December 5, 2022
• Primary Completion: February 10, 2023
• Study Completion: April 7, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)