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Sucrosomia Vitamin D appears to be 2 X more bio-available– RCT Aug 2023

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A comparative absorption study of sucrosomial® orodispersible vitamin D3 supplementation vs. a reference chewable tablet and soft gel capsule vitamin D3 in improving circulatory 25(OH)D levels in healthy adults with vitamin D deficiency—Results from a prospective randomized clinical trial

Front. Nutr., 17 August 2023 Volume 10 - 2023 | https://doi.org/10.3389/fnut.2023.1221685
Aasiya Bano1† Saida Abrar2† Elisa Brilli3 Germano Tarantino3 Ali Akbar Bugti4 Marco Fabbrini5 Gabriele Conti5 Silvia Turroni5 Mahroo Bugti6 Fauzia Afridi7 Shah Mureed8 Hakeem Zada9 Ikram Din Ujjan10 Saadia Ashraf11 Aamir Ghafoor12 Saeed Khan13 Amjad Khan14,15*

Second Trial
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Objective: We aimed to compare the absorption of an innovative phospholipids-sucrester matrix biodelivery vehicle-based (sucrosomial®) orodispersible Vit D3 preparation against a reference chewable tablet and soft gel capsule (SGC) Vit D3 formulations in Vit D-deficient healthy adults.

Methods: In study 1, 25 subjects were randomized to receive a weekly single dose of 200,000 IU of sucrosomial® Vit D3 (n = 12) or chewable tablet Vit D3 (n = 13) for 3 weeks.
In study 2, 20 subjects were randomized to receive a single dose of 200,000 IU every other week of sucrosomial® Vit D3 (n = 10) or SGC Vit D3 (n = 10) for 6 weeks. Circulatory 25-hydroxyvitamin D3 [25(OH)D] levels were reassessed after 2, 3, and 6 weeks in study 1 and after 4 and 6 weeks in study 2.

Results: In study 1, after 2 weeks, circulatory 25(OH)D levels increased significantly in both Vit D3 treatment groups (p < 0.0001) but improved markedly in the sucrosomial® Vit D3 group, with no further considerable change after 3 and 6 weeks in both groups. Overall, at all three follow-ups, sucrosomial® Vit D3 treatment achieved significantly higher and sustained 25(OH)D levels (p < 0.001). In study 2, after 4 weeks, both Vit D3 treatment groups showed significant improvement in circulatory 25(OH)D levels (p < 0.0001) but substantially higher in the sucrosomial® group with statistically significant differences between the two treatment groups (p = 0.02). At the 6-week follow-up, only subjects in the sucrosomial® Vit D3 group showed a further increase in circulatory 25(OH)D levels (p = 0.049), but no further significant changes in the levels of the SGC Vit D3 group (p = 0.062), showing a statistically significant difference between the two treatment groups (p = 0.002). The Vit D3 treatment was well tolerated by all participants, and no treatment-emergent effects or serious adverse events were reported.

Conclusion: Our results suggest that the sucrosomial® Vit D3 preparation absorbs efficiently in the GI system, achieving adequately higher and sustained circulatory Vit D levels in VDD, and thus can effectively contribute to the body protection against VDD-associated health conditions.

Clinical trial registration: clinicaltrials.gov, identifier: NCT05706259.
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55 References
  1. Bikle Daniel D. vitamin D metabolism, mechanism of action, and clinical applications. ChemBiol (2014) 21:319-29. doi: 10.1016/j.chembiol.2013.12.016
  2. Janousek J, Pilarova V, Macakova K, Nomura A, Veiga-Matos J. Silva DDd, et al. vitamin D: sources, physiological role, biokinetics, deficiency, therapeutic use, toxicity, and overview of analytical methods for detection of vitamin D and its metabolites. Crit Rev Clin Lab Sci. (2022) 59:517-54. doi: 10.1080/10408363.2022.2070595
  3. Baeke F, Takiishi T, Korf H, Gysemans C, Mathieu C. vitamin D: modulator of the immune system. Curr Opin Pharmacol. (2010) 10:482-96. doi: 10.1016/j.coph.2010.04.001
  4. Lagishetty V, Liu NQ, Hewison M. vitamin D metabolism and innate immunity. Mol Cell Endocrinol. (2011) 347:97-105. doi: 10.1016/j.mce.2011.04.015
  5. Pludowski P, Holick MF, Grant WB, Konstantynowicz J, Mascarenhas MR, Haq A, et al. vitamin D supplementation guidelines. J Steroid Biochem Mol Biol. (2018) 175:125-35. doi: 10.1016/j.jsbmb.2017.01.021
  6. Katz J, Yue S, Xue W. Increased risk for COVID-19 in patients with vitamin D deficiency. Nutrition. (2021) 84:111106. doi: 10.1016/j.nut.2020.111106
  7. Ao T, Kikuta J, Ishii M. The effects of vitamin D on immune system and inflammatory diseases. Biomolecules. (2021) 11:624. doi: 10.3390/biom11111624
  8. Charoenngam N, Holick MF. Immunologic effects ofvitamin D on human health and disease. Nutrients. (2020) 12:97. doi: 10.3390/nu12072097
  9. Gois PHF, Ferreira D, Olenski S, Seguro AC. vitamin D and infectious diseases: simple bystander or contributing factor? Nutrients. (2017) 9:651. doi: 10.3390/nu9070651
  10. Iqtadar S, Khan A, Mumtaz SU, Livingstone S, Chaudhry MNA, Raza N, et al. vitamin D deficiency (VDD) and susceptibility towards severe dengue fever-a prospective cross-sectional study of hospitalized dengue fever patients from Lahore, Pakistan. TropMedInfectDis. (2023) 8:43. doi: 10.3390/tropicalmed8010043
  11. L Bishop E, Ismailova A, Dimeloe S, Hewison M, White JH. vitamin D and immune regulation: antibacterial, antiviral, anti-inflammatory. JBMR Plus. (2021) 5:e10405. doi: 10.1002/jbm4.10405
  12. Thacher TD, Clarke BL. vitamin D insufficiency. Mayo ClinProc. (2011) 86:50­60. doi: 10.4065/mcp.2010.0567
  13. Amrein K, Scherkl M, Hoffmann M, Neuwersch-Sommeregger S, Kostenberger M, Tmava Berisha A. et al. vitamin D deficiency 20: an update on the current status worldwide. EurJClin Nutr. (2020) 74:1498-513. doi: 10.1038/s41430-020-0558-y
  14. Lips P, Cashman KD, Lamberg-Allardt C, Bischoff-Ferrari HA, Obermayer­Pietsch B, Bianchi ML, et al. Current vitamin D status in european and middle east countries and strategies to prevent vitamin d deficiency: a position statement of the european calcified tissue society. Eur J Endocrinol. (2019) 180:P23- 54. doi: 10.1530/EJE-18-0736
  15. Holick MF. vitamin D deficiency. N Engl J Med. (2007) 357:266­81. doi: 10.1056/NEJMra070553
  16. Nair R, Maseeh A. vitamin D: the “sunshine" vitamin. J Pharmacol Pharmacother. (2012) 3:118-26. doi: 10.4103/0976-500X.95506
  17. Riaz H, Finlayson AE, Bashir S, Hussain S, Mahmood S, Malik F, et al. Prevalence of vitamin D deficiency in Pakistan and implications for the future. Expert Rev Clin Pharmacol. (2016) 9:329-38. doi: 10.1586/17512433.2016.1122519
  18. Macdonald HM, Mavroeidi A, Fraser WD, Darling AL, Black AJ, Aucott L, et al. Sunlight and dietary contributions to the seasonal vitamin D status of cohorts of healthy postmenopausal women living at northerly latitudes: a major cause for concern? Osteoporos Int. (2011) 22:2461-72. doi: 10.1007/s00198-010-1467-z
  19. Lo CW, Paris PW, Clemens TL, Nolan J, Holick MF. vitamin D absorption in healthy subjects and in patients with intestinal malabsorption syndromes. Am J Clin Nutr. (1985) 42:644-9. doi: 10.1093/ajcn/42.4.644
  20. Cupone IE, Dellera E, Marra F, Giori AM. Development and characterization of an orodispersible film for vitamin d3 supplementation. Molecules. (2020) 25:851. doi: 10.3390/molecules25245851
  21. Fassio A, Adami G, Rossini M, Giollo A, Caimmi C, Bixio R, et al. Pharmacokinetics of oral cholecalciferol in healthy subjects with vitamin d deficiency: a randomized open-label study. Nutrients. (2020) 12:53. doi: 10.3390/nu12061553
  22. Hermes WA, Alvarez JA, Lee MJ, Chesdachai S, Lodin D, Horst R, et al. Prospective, randomized, double-blind, parallel-group, comparative effectiveness clinical trial comparing a powder vehicle compound of vitamin D with an oil vehicle compound in adults with cystic fibrosis. JPENJParenter Enteral Nutr. (2017) 41:952­8. doi: 10.1177/0148607116629673
  23. Jetter A, Egli A, Dawson-Hughes B, Staehelin HB, Stoecklin E, Goessl R, et al. Pharmacokinetics of oral vitamin D(3) and calcifediol. Bone. (2014) 59:14­9. doi: 10.1016/j.bone.2013.10.014
  24. Mentaverri R, Souberbielle JC, Brami G, Daniel C, Fardellone P. Pharmacokinetics of a new pharmaceutical form of vitamin D3 100,000 IU in soft capsule. Nutrients. (2019) 11:703. doi: 10.3390/nu11030703
  25. Radicioni M, Caverzasio C, Rovati S, Giori AM, Cupone I, Marra F, et al. Comparative bioavailability study of a new vitamin D3 orodispersible film versus a marketed oral solution in healthy volunteers. Clin Drug Investig. (2022) 42:151 — 61. doi: 10.1007/s40261 -021-01113-7
  26. Satia MC, Mukim AG, Tibrewala KD, Bhavsar MS, A. randomized two way cross over study for comparison of absorption of vitamin D3 buccal spray and soft gelatin capsule formulation in healthy subjects and in patients with intestinal malabsorption. NutrJ. (2015) 14:114. doi: 10.1186/s12937-015-0105-1
  27. Wagner CL, Shary JR, Nietert PJ, Wahlquist AE, Ebeling MD, Hollis BW. Bioequivalence studies of vitamin D gummies and tablets in healthy adults: results of a cross-over study. Nutrients. (2019) 11:17. doi: 10.3390/nu11051023
  28. Maurya VK, Aggarwal M. Factors influencing the absorption of vitamin D in GIT: an overview. J Food Sci Technol. (2017) 54:3753­65. doi: 10.1007/s13197-017-2840-0
  29. Gómez-Ramírez S, Brilli E, Tarantino G, Muñoz M. sucrosomial(®) iron: a new generation iron for improving oral supplementation. Pharmaceuticals. (2018) 11:97. doi: 10.3390/ph11040097
  30. Benjamini Y. Discovering the false discovery rate. J Royal Stat Soc Series B Stat Methodol. (2010) 72:405-16. doi: 10.1111/j.1467-9868.2010.00746.x
  31. R Core Team. R: A Language and Environmentfor Statistical Computing. (2020). Available online at: https://www.r-project.org/ (accessed June 11, 2023).
  32. Wickham H. Elegant Graphics for Data Analysis. New York, NY: Springer Cham (2016).
  33. Barger-Lux MJ, Heaney RP, Dowell S, Chen TC, Holick MF. vitamin D and its major metabolites: serum levels after graded oral dosing in healthy men. Osteoporos Int. (1998) 8:222-30. doi: 10.1007/s001980050058
  34. Brilli E, Romano A, Fabiano A, Zambito Y, Di Raimondo F, Tarantino G. sucrosomial technology is able to promote ferric iron absorption: pre-clinical and clinical evidences. Blood. (2016) 128:3618. doi: 10.1182/blood.V128.22.3618.3618
  35. Du M, Chang C, Zhang X, Zhang Y, Radford MJ, Gahler RJ, et al. Designing vitamin D3 formulations: an in vitro investigation using a novel micellar delivery system. Nutraceuticals. (2023) 3:290-305. doi: 10.3390/nutraceuticals3020023
  36. Fabiano A, Brilli E, Mattii L, Testai L, Moscato S, Citi V, et al. Ex Vivo and in Vivo study of sucrosomial(®) iron intestinal absorption and bioavailability. Int J Mol Sci. (2018) 19:722. doi: 10.3390/ijms19092722
  37. Takaishi N, Satsu H, Shimizu M. Enhanced daunomycin accumulation in human intestinal Caco-2 cells from non-ionic food emulsifiers unrelated to the p-glycoprotein inhibitory mechanism. Biosci Biotechnol Biochem. (2006) 70:2703­11. doi: 10.1271/bbb.60306
  38. Quintanar-Guerrero D, Ganem-Quintanar A, Allémann E, Fessi H, Doelker E. Influence of the stabilizer coating layer on the purification and freeze-drying of poly(D, L-lactic acid) nanoparticles prepared by an emulsion-diffusion technique. J Microencapsul. (1998) 15:107-19. doi: 10.3109/02652049809006840
  39. Bertani L, Trico D, Zanzi F, Baiano Svizzero G, Coppini F, de Bortoli N, et al. Oral sucrosomial iron is as effective as intravenous ferric carboxy-maltose in treating anemia in patients with ulcerative colitis. Nutrients. (2021) 13:2. doi: 10.3390/nu130 20608
  40. Narang NC, Sharma J, Baba S. Sublingual mucosa as a route for systemic drug delivery. JPharmacol Pharmacother. (2011) 3:118-26.
  41. Hahn TJ, Squires AE, Halstead LR, Strominger DB. Reduced serum 25- hydroxyvitamin D concentration and disordered mineral metabolism in patients with cystic fibrosis. J Pediatr. (1979) 94:38-42. doi: 10.1016/S0022-3476(79) 80346-7
  42. Driscoll RH, Meredith SC, Sitrin M, Rosenberg IH. vitamin D deficiency and bone disease in patients with Crohn’s disease. Gastroenterology. (1982) 83:1252­8. doi: 10.1016/S0016-5085(82)80135-2
  43. Compston JE, Ayers AB, Horton LW, Tighe JR, Creamer B. Osteomalacia after small-intestinal resection. Lancet. (1978) 1:9-12. doi: 10.1016/S0140-6736(78) 90358-6
  44. Markestad T, Aksnes L, Finne PH, Aarskog D. Decreased vitamin D absorption after limited jejunal resection in a premature infant. J Pediatr. (1982) 101:1001­8. doi: 10.1016/S0022-3476(82)80031-0
  45. Danielsson A, Lorentzon R, Larsson SE. Intestinal absorption and 25- hydroxylation of vitamin D in patients with primary biliary cirrhosis. Scand J Gastroenterol. (1982) 17:349-55. doi: 10.3109/00365528209182066
  46. Matloff DS, Kaplan MM, Neer RM, Goldberg MJ, Bitman W, Wolfe HJ. Osteoporosis in primary biliary cirrhosis: effects of 25-hydroxyvitamin D3 treatment. Gastroenterology. (1982) 83:97-102. doi: 10.1016/S0016-5085(82)80291-6
  47. Caprio M, Infante M, Calanchini M, Mammi C, Fabbri A. vitamin D: not just the bone. Evidence for beneficial pleiotropic extraskeletal effects Eating and Weight Disorders-Studies on Anorexia. Bulimia Obesity. (2017) 22:27­41. doi: 10.1007/s40519-016-0312-6
  48. Gatti D, Idolazzi L, Fassio A. vitamin D: not just bone, but also immunity. MinervaMed. (2016) 107:452-60.
  49. Martineau AR, Jolliffe DA, Hooper RL, Greenberg L, Aloia JF, Bergman P, et al. vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ. (2017) 356:i6583. doi: 10.1136/bmj.i6583

Vitamin D nanoemulsion appears to also have similar good bio-availabilty and faster response

Sucrosomia Vitamin D appears to be 2 X more bio-available– RCT Aug 2023        
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