title: A Randomised, Cross-Over Study to Estimate the Influence of Food on the 25-Hydroxyvitamin D₃ Serum Level after Vitamin D₃ Supplementation.
abstract: Vitamin D₃ is known to be liposoluble and its release could be a factor limiting the rate of absorption. It was presumed that the presence of fat could favor absorption of vitamin D₃. However, as bioavailability is related not only to the active molecules but also to the formulations and excipients used, the optimization of the pharmaceutical form of vitamin D₃ is also important. The objective of this study was to evaluate if there is a food effect on absorption when a high dose of vitamin D₃ is completely solubilized in an oily solution. In the present cross-over study, 88 subjects were randomized and received a single dose of 50,000 IU of vitamin D₃ in fasting state or with a standardized high-fat breakfast. Assessment of serum concentrations of 25 hydroxyvitamin D₃ (25(OH)D₃) was performed three, five, seven, 14, 30 and 60 days after supplementation. In fed and fast conditions, the 25(OH)D₃ serum concentrations were significantly higher than the baseline value three days after administration and remained significantly higher during the first month. No significant difference between fasting vs. fed conditions was observed. It is therefore concluded that the vitamin D₃ absorption from an oily solution was not influenced by the presence or absence of a meal.
authors.affiliation: Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège 4000, Belgium. Etienne.cavalier@chu.ulg.ac.be.
authors.forename: Etienne
authors.initials: E
authors.lastname: Cavalier
authors.affiliation: Department of Clinical Pharmacology, ATC SA, Liège 4000, Belgium. bernard.jandrain@atc-pharma.be.
authors.forename: Bernard
authors.initials: B
authors.lastname: Jandrain
authors.affiliation: Clinical Department, Laboratoires SMB SA, Brussels 1080, Belgium. mcoff@smb.be.
authors.forename: Monte
authors.initials: M
authors.lastname: Coffiner
authors.affiliation: Clinical Department, Laboratoires SMB SA, Brussels 1080, Belgium. sdsil@smb.be.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Da Silva
authors.affiliation: Clinical Department, Laboratoires SMB SA, Brussels 1080, Belgium. sdeni@smb.be.
authors.forename: Sophie
authors.initials: S
authors.lastname: De Niet
authors.affiliation: Clinical Department, Laboratoires SMB SA, Brussels 1080, Belgium. fvdbi@smb.be.
authors.forename: Francis
authors.initials: F
authors.lastname: Vanderbist
authors.affiliation: Laboratoire d'Explorations Fonctionnelles, Hôpital Necker-Enfants Malades, Paris 75014, France. jean-claude.souberbielle@nck.aphp.fr.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Souberbielle
mesh_terms: D000328:Adult; D001530:Belgium; D001682:Biological Availability; D015415:Biomarkers / Q000097:blood; D062408:Breakfast; D002112:Calcifediol / Q000097:blood*; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004041:Dietary Fats / Q000008:administration & dosage* / Q000378:metabolism; D019587:Dietary Supplements; D005260:Female; D018565:Food-Drug Interactions; D065569:Gastrointestinal Absorption; D006801:Humans; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period; D055815:Young Adult
chemical_list: D015415:Biomarkers; D004041:Dietary Fats; D002762:Cholecalciferol; D002112:Calcifediol
keywords: 25-hydroxyvitamin D3; absorption; fasting; high fat