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.

Abstract

Background: Vitamin D participates in the biological function of the innate and adaptive immune system and inflammation. We aim to specify the effectiveness of the vitamin D supplementation on the side effects BioNTech, Pfizer vaccination, and immunoglobulin G response against severe acute respiratory syndrome coronavirus 2 in subjects tested positive for coronavirus disease 2019 (COVID-19).

Methods: In this multi-center randomized clinical trial, 498 people tested positive for COVID-19 were divided into 2 groups, receiving vitamin D capsules or a placebo (1 capsule daily, each containing 600 IU of vitamin D) over 14-16 weeks. Anthropometric indices and biochemical parameters were measured before and after the second dose of vaccination.

Result: Fourteen to 16 weeks after supplementation, the intervention group had an immunoglobulin G (IgG) increase of 10.89 ± 1.2 g/L, while the control group had 8.89 ± 1.3 g/L, and the difference was significant between both groups (p = 0.001). After the second dose of vaccination, the supplement group significantly increased their 25-hydroxy vitamin D from initially 28.73 ± 15.6 ng/mL and increased to 46.48 ± 27.2 ng/mL, and the difference between them was significant. Those with a higher body mass index (BMI) had the most of symptoms, and the difference of side effects according to BMI level was significantly different. In 8 weeks after supplementation obese participants had the lowest IgG levels than overweight or normal subjects. The proportion of all types of side effects on the second dose was significantly diminished compared with the first dose in the intervention group.

Conclusion: Supplementation of 600 IU of vitamin D3 can reduce post-vaccination side effects and increase IgG levels in participants who received BioNTech, Pfizer vaccine.

Trial registration: ClinicalTrials.gov Identifier: NCT05851313.