drugset / Trial / NCT03783273
The Influence of Food Matrix Delivery System on the Bioavailability of Vitamin D3
RandomizedCrossoverSingle-blindTreatment
Summary
This study investigates the influence of different food matrices on the bioavailability of vitamin D. Although most vitamin D comes from skin synthesis in response to sun exposure, dietary intake is also important - especially during winter time where there is no endogenous production of vitamin D in Denmark. A way to maintain an adequate vitamin D status is to supplement either as tablets/droplets or as fortified food. However, there seems to be an inter-individual variation in response to supplementation. This study aims to investigate whether this variation in absorption of vitamin D may depend on delivery system.
Timeline
- Start
- 2019-01-08
- Primary completion
- 2020-05-26
- Completion
- 2020-05-26
Publications
- Background Pedersen JN, Frislev HS, Pedersen JS, Otzen DE. Using protein-fatty acid complexes to improve vitamin D stability. J Dairy Sci. 2016 Oct;99(10):7755-7767. doi: 10.3168/jds.2016-11343. Epub 2016 Jul 27.
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- Background Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204.
- Background Shab-Bidar S, Bours S, Geusens PP, Kessels AG, van den Bergh JP. Serum 25(OH)D response to vitamin D3 supplementation: a meta-regression analysis. Nutrition. 2014 Sep;30(9):975-85. doi: 10.1016/j.nut.2013.12.020. Epub 2014 Jan 10.
- Background Shab-Bidar S, Bours SP, Geusens PP, van der Velde RY, Janssen MJ, van den Bergh JP. Suboptimal effect of different vitamin D3 supplementations and doses adapted to baseline serum 25(OH)D on achieved 25(OH)D levels in patients with a recent fracture: a prospective observational study. Eur J Endocrinol. 2013 Oct 1;169(5):597-604. doi: 10.1530/EJE-13-0068. Print 2013 Nov.
- Background Binkley N, Borchardt G, Siglinsky E, Krueger D. DOES VITAMIN D METABOLITE MEASUREMENT HELP PREDICT 25(OH)D CHANGE FOLLOWING VITAMIN D SUPPLEMENTATION? Endocr Pract. 2017 Apr 2;23(4):432-441. doi: 10.4158/EP161517.OR. Epub 2017 Jan 17.
- Background Tanner JT, Smith J, Defibaugh P, Angyal G, Villalobos M, Bueno MP, McGarrahan ET, Wehr HM, Muniz JF, Hollis BW, et al. Survey of vitamin content of fortified milk. J Assoc Off Anal Chem. 1988 May-Jun;71(3):607-10.
- Background Holick MF, Shao Q, Liu WW, Chen TC. The vitamin D content of fortified milk and infant formula. N Engl J Med. 1992 Apr 30;326(18):1178-81. doi: 10.1056/NEJM199204303261802.
- Background Chen TC, Shao A, Heath H 3rd, Holick MF. An update on the vitamin D content of fortified milk from the United States and Canada. N Engl J Med. 1993 Nov 11;329(20):1507. doi: 10.1056/NEJM199311113292021. No abstract available.
- Background Gallagher JC, Sai A, Templin T 2nd, Smith L. Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):425-37. doi: 10.7326/0003-4819-156-6-201203200-00005.
- Background Nelson ML, Blum JM, Hollis BW, Rosen C, Sullivan SS. Supplements of 20 microg/d cholecalciferol optimized serum 25-hydroxyvitamin D concentrations in 80% of premenopausal women in winter. J Nutr. 2009 Mar;139(3):540-6. doi: 10.3945/jn.108.096180. Epub 2009 Jan 21.
- Background Blum M, Dallal GE, Dawson-Hughes B. Body size and serum 25 hydroxy vitamin D response to oral supplements in healthy older adults. J Am Coll Nutr. 2008 Apr;27(2):274-9. doi: 10.1080/07315724.2008.10719700.
- Background Wagner D, Hanwell HE, Schnabl K, Yazdanpanah M, Kimball S, Fu L, Sidhom G, Rousseau D, Cole DE, Vieth R. The ratio of serum 24,25-dihydroxyvitamin D(3) to 25-hydroxyvitamin D(3) is predictive of 25-hydroxyvitamin D(3) response to vitamin D(3) supplementation. J Steroid Biochem Mol Biol. 2011 Sep;126(3-5):72-7. doi: 10.1016/j.jsbmb.2011.05.003. Epub 2011 May 13.
- Background Fu L, Yun F, Oczak M, Wong BY, Vieth R, Cole DE. Common genetic variants of the vitamin D binding protein (DBP) predict differences in response of serum 25-hydroxyvitamin D [25(OH)D] to vitamin D supplementation. Clin Biochem. 2009 Jul;42(10-11):1174-7. doi: 10.1016/j.clinbiochem.2009.03.008. Epub 2009 Mar 18.
- Background Zhao LJ, Zhou Y, Bu F, Travers-Gustafson D, Ye A, Xu X, Hamm L, Gorsage DM, Fang X, Deng HW, Recker RR, Lappe JM. Factors predicting vitamin D response variation in non-Hispanic white postmenopausal women. J Clin Endocrinol Metab. 2012 Aug;97(8):2699-705. doi: 10.1210/jc.2011-3401. Epub 2012 May 14.
- Background Borel P, Caillaud D, Cano NJ. Vitamin D bioavailability: state of the art. Crit Rev Food Sci Nutr. 2015;55(9):1193-205. doi: 10.1080/10408398.2012.688897.
- Background Reboul E. Intestinal absorption of vitamin D: from the meal to the enterocyte. Food Funct. 2015 Feb;6(2):356-62. doi: 10.1039/c4fo00579a.
- Background Thompson GR, Lewis B, Booth CC. Absorption of vitamin D3-3H in control subjects and patients with intestinal malabsorption. J Clin Invest. 1966 Jan;45(1):94-102. doi: 10.1172/JCI105327. No abstract available.
- Background Iqbal J, Hussain MM. Intestinal lipid absorption. Am J Physiol Endocrinol Metab. 2009 Jun;296(6):E1183-94. doi: 10.1152/ajpendo.90899.2008. Epub 2009 Jan 21.
- Background Raimundo FV, Lang MA, Scopel L, Marcondes NA, Araujo MG, Faulhaber GA, Furlanetto TW. Effect of fat on serum 25-hydroxyvitamin D levels after a single oral dose of vitamin D in young healthy adults: a double-blind randomized placebo-controlled study. Eur J Nutr. 2015 Apr;54(3):391-6. doi: 10.1007/s00394-014-0718-8. Epub 2014 May 23.
- Background Tangpricha V, Koutkia P, Rieke SM, Chen TC, Perez AA, Holick MF. Fortification of orange juice with vitamin D: a novel approach for enhancing vitamin D nutritional health. Am J Clin Nutr. 2003 Jun;77(6):1478-83. doi: 10.1093/ajcn/77.6.1478.
- Background Biancuzzo RM, Young A, Bibuld D, Cai MH, Winter MR, Klein EK, Ameri A, Reitz R, Salameh W, Chen TC, Holick MF. Fortification of orange juice with vitamin D(2) or vitamin D(3) is as effective as an oral supplement in maintaining vitamin D status in adults. Am J Clin Nutr. 2010 Jun;91(6):1621-6. doi: 10.3945/ajcn.2009.27972. Epub 2010 Apr 28.
- Background Reboul E, Goncalves A, Comera C, Bott R, Nowicki M, Landrier JF, Jourdheuil-Rahmani D, Dufour C, Collet X, Borel P. Vitamin D intestinal absorption is not a simple passive diffusion: evidences for involvement of cholesterol transporters. Mol Nutr Food Res. 2011 May;55(5):691-702. doi: 10.1002/mnfr.201000553. Epub 2011 Jan 31.
- Background Masson CJ, Plat J, Mensink RP, Namiot A, Kisielewski W, Namiot Z, Fullekrug J, Ehehalt R, Glatz JF, Pelsers MM. Fatty acid- and cholesterol transporter protein expression along the human intestinal tract. PLoS One. 2010 Apr 29;5(4):e10380. doi: 10.1371/journal.pone.0010380.
- Background Desmarchelier C, Borel P, Goncalves A, Kopec R, Nowicki M, Morange S, Lesavre N, Portugal H, Reboul E. A Combination of Single-Nucleotide Polymorphisms Is Associated with Interindividual Variability in Cholecalciferol Bioavailability in Healthy Men. J Nutr. 2016 Dec;146(12):2421-2428. doi: 10.3945/jn.116.237115. Epub 2016 Oct 26.
- Background Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.
- Background Kazmi SA, Vieth R, Rousseau D. Vitamin D3 fortification and quantification in processed dairy products. International Dairy Journal 17:753-759, 2007
- Background Cormick G, Ciapponi A, Cafferata ML, Belizan JM. Calcium supplementation for prevention of primary hypertension. Cochrane Database Syst Rev. 2015 Jun 30;2015(6):CD010037. doi: 10.1002/14651858.CD010037.pub2.
- Background Billington EO, Bristow SM, Gamble GD, de Kwant JA, Stewart A, Mihov BV, Horne AM, Reid IR. Acute effects of calcium supplements on blood pressure: randomised, crossover trial in postmenopausal women. Osteoporos Int. 2017 Jan;28(1):119-125. doi: 10.1007/s00198-016-3744-y. Epub 2016 Aug 20.
- Background Van Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, Schillaci G, Segers P, Vermeersch S, Weber T; Artery Society; European Society of Hypertension Working Group on Vascular Structure and Function; European Network for Noninvasive Investigation of Large Arteries. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012 Mar;30(3):445-8. doi: 10.1097/HJH.0b013e32834fa8b0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 200 ug | Oral |