Objective The goal of this randomized placebo-controlled clinical trial was to investigate the therapeutic efficacy of oral 25-hydroxyvitamin D 3 [25(OH)D 3 ] in improving vitamin D status in vitamin D deficient/insufficient patients infected with the SARS-CoV-2 (COVID-19) virus. Methods This is a multicenter randomized double blinded randomized placebo-controlled clinical trial. Participants were recruited from three hospitals that are affiliated to [Institution Blinded for Review], and [Institution Blinded for Review]. Results A total 106 hospitalized patients who had a circulating concentration of 25(OH)D <30 ng/ml were enrolled in this study. Within 30 and 60 days 79.4% (26 out of 34) and 100% (24 out of 24) of the patients who received 25(OH)D 3 became sufficient whereas ≤12.5% the patients in the placebo group became sufficient during 2 months follow-up. We observed an overall lower trend for hospitalization, ICU duration, needing ventilator assistance and mortality in the 25(OH)D3 group compared with placebo group but they weren’t statistically significant. Treatment with oral 25(OH)D 3 was associated with a significant increase in the lymphocyte percentage and decrease in the ratio of neutrophils to lymphocytes (NLR) in the patients. The lower NLR was significant associated with reduced ICU admission days and mortality. Conclusion Our analysis indicated that oral 25-hydroxyvitamin D 3 was able to correct vitamin D deficiency/insufficiency in COVID-19 patients that resulted in improved immune function by increasing blood lymphocyte percentage. RCTs with a larger sample size and with higher dose of 25(OH)D3 maybe needed to confirm the potential effect of 25(OH)D3 on reducing clinical outcomes in COVID-19 patients. Ethics and Dissemination The study protocol was approved by the Ethics Committee of [Institution Blinded for Review]. (Approval Number: IR.TUMS.VCR.REC.1399.061). Dissemination plans include academic publications, conference presentations and social media. Trial registration The protocol was registered with the Iranian Registry of Clinical Trials (IRCT) on April 11, 2020 [Number Blinded for Review]. and U.S. National Institutes of Health [Number Blinded for Review] on May 11, 2020.

Background In this study, we aimed to determine the risk association between vitamin D binding protein (VDBP) polymorphism in patients with multiple sclerosis (MS) in a MS biobank and the difference in VDBP serum levels in MS patients who were recently diagnosed. Method The current case-control study was performed on 296 MS patients and 313 controls. Thereafter, two common missense VDBP polymorphisms, named rs7041and rs4588, were evaluated in all the participants. Serum levels of vitamin D and vitamin D binding protein were assessed in 77 MS patients who were diagnosed since one year ago and in 67 healthy people who were matched in terms of age and sex. Result The frequency distributions of VDBP genotypes and alleles of SNP rs7041 and rs4588 were observed to be similar in both the MS and control groups (p > 0.05). The VDBP haplotypes, as Gc2/Gc2, Gc1/Gc1, and Gc1/Gc2, were found to be similar in the MS and control groups (p > 0.05). In subgroup analysis, circulating VDBP was lower in MS patients (Ln-VDBP (μgr/ml): 3.64 ± 0.91 vs. 5.31 ± 0.77, p = 0.0001) even after adjusting for vitamin D levels, body mass index, and taking vitamin D supplement. There was no significant association between VDBP haplotypes and vitamin D levels in the two groups. Conclusion The present study suggested an association between lower levels of circulating VDBP and multiple sclerosis in newly diagnosed patients. However, the VDBP causative role in the development of MS is still unclear, so it needs more studies.

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