AB1019 THE EFFECTS OF THREE DIFFERENT VITAMIN D3 SUPPLEMENTATION REGIMENS IN DEFICIENT SUBJECTS ON INFLAMMATORY CYTOKINES – A RANDOMISED OPEN-LABEL PARALLEL GROUPS STUDY

Abstract

BackgroundThe effects of cholecalciferol supplementation on the regulation of inflammatory cytokines are still unclear.ObjectivesThis is a preliminary analysis on exploratory outcomes the DIBA/11 RCT [1,2] and aimed to compare the effects on serum inflammatory cytokines of three different regimes of cholecalciferol supplementation in vitamin D-deficient subjects.MethodsWe evaluated, in healthy subjects affected by vitamin D deficiency (defined as 25OHD<20 ng/mL), 18 to 60 years of age, the efficacy of three different oral supplementation regimens: daily 10,000Iu administered for 8 weeks (group A), weekly 50,000Iu (group B) for 12 weeks and biweekly 100,000Iu (group C) for 12 weeks.Serum TNFα, interleukin-6 (IL6), interleukin-17 (IL17) and interleukin-10 (IL10) were dosed at baseline, Day 28, 53, 84 and 112. This study was approved by the institutional research committee (protocol identification: DIBA/11,EudraCT Number:2017-000194-36). Supported by Abiogen Pharma, Italy).ResultsA total of 75 subjects were randomized to receive one supplementation regimen. The descriptive of the sample at baseline and relative cytokines levels at the various observation points are reported in Table 1. The absolute changes of IL6, IL17 and IL10 are depicted in Figure 1. No significant differences were found among the three groups. TNFα was undetectable at baseline and at any time point.Table 1.anthropometrics and laboratory parameters at baseline (mean values ± standard deviation)ParameterAll patients (N=75)Daily 10.000 Ui(N = 25)Weekly 50.000 Ui(n = 25)Biweekly 100.000 Ui(N = 25)p-value (ANOVA)M:F31:4412:137:1812:13NSAge (years)34.1 ± 10.230.2 ± 9.936.7 ± 8.735.4 ± 11.00.059Body Weight (kg)66.7 ± 12.465.8 ± 13.267.8 ± 10.866.6 ± 13.7NSBMI23.1 ± 2.622.55 ± 2.723.8 ± 2.222.8 ± 2.7NSBaseline 25OHD (ng/mL)13.5 ± 3.714.6 ± 3.912.8 ± 313.5 ± 4.1NSBaseline IL-6 (pg/mL)1.3 ± 1.20.9 ± 0.61.4 ± 1.61.6 ± 1.3NSBaseline IL-17 (pg/mL)0.4 ± 1.80.7 ± 30.2 ± 1.10.2 ± 0.7NSBaseline IL-10 (pg/mL)0.9 ± 0.90.8 ± 0.71.2 ± 1.20.8 ± 0.7NSFigure 1.absolute changes of IL17, IL6 and IL10. *p<0.05 vs baseline.ConclusionIn the overall cohort we found slight decreases in serum IL6 and IL17 serum levels. No differences were found among groups.References[1]Fassio A, Adami G, Rossini M, et al. Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study. Nutrients. 2020;12(6).[2]Fassio A, Gatti D, Rossini M, et al. Pharmacodynamics of Oral Cholecalciferol in Healthy Individuals with Vitamin D Deficiency: A Randomized Open-Label Study. Nutrients. 2021;13(7):2293.Disclosure of InterestsAngelo Fassio: None declared, Davide Gatti Speakers bureau: Amgen, Celgene Eli-Lilly, MSD-Italia, Organon, UCB., Paid instructor for: Amgen, Celgene Eli-Lilly, MSD-Italia, Organon, UCB., Matteo Gatti: None declared, Maurizio Rossini Speakers bureau: Abiogen, Amgen, Abbvie, BMS, Celgene, Eli-Lilly, Galapagos, Grunenthal, MSD, Novartis, Pfizer, Sanofi, Sandoz, Theramex, UCB., Eugenia Bertoldo: None declared, Giovanni Adami: None declared