title: A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency.
abstract: Many people worldwide are vitamin D (VTD) deficient or insufficient, and there is still no consensus on the dose of VTD that should be administered to achieve a 25(OH)D concentration of 20 or 30 ng/mL. In this study, we aimed to determine an adapted supplementation of VTD able to quickly and safely increase the vitamin D status of healthy adults with low 25(OH)D. One hundred and fifty (150) subjects were randomized into three groups, each to receive, orally, a loading dose of 50,000, 100,000 or 200,000 IU of VTD3 at Week 0, followed by 25,000, 50,000 or 100,000 IU at Week 4 and Week 8. Whereas 25(OH)D baseline values were not different between groups (p = 0.42), a significant increase was observed at Week 12 (p < 0.0001) with a mean change from baseline of 7.72 ± 5.08, 13.3 ± 5.88 and 20.12 ± 7.79 ng/mL. A plateau was reached after eight weeks. No related adverse event was recorded. This study demonstrated a linear dose-response relationship with an increase in 25(OH)D levels proportional to the dose administered. In conclusion, a loading dose of 200,000 IU VTD3 followed by a monthly dose of 100,000 IU is the best dosing schedule to quickly and safely correct the VTD status.
authors.affiliation: Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège B-4000, Belgium. mlschleck@chu.ulg.ac.be.
authors.forename: Marie-Louise
authors.initials: ML
authors.lastname: Schleck
authors.affiliation: Laboratoire d'Explorations fonctionnelles, Hôpital Necker-Enfants malades, Paris 75015, France. jean-claude.souberbielle@nck.aphp.fr.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Souberbielle
authors.affiliation: Department of Clinical Pharmacology, ATC SA, Liège B-4000, Belgium. Bernard.jandrain@atc-pharma.com.
authors.forename: Bernard
authors.initials: B
authors.lastname: Jandrain
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: Division of Diabetes, Nutrition and Metabolic Disorders, CHU Sart Tilman, University of Liège, Liège B-4000, Belgium. andre.scheen@chu.ulg.ac.be.
authors.forename: André
authors.initials: A
authors.lastname: Scheen
authors.affiliation: Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège B-4000, Belgium. Etienne.cavalier@chu.ulg.ac.be.
authors.forename: Etienne
authors.initials: E
authors.lastname: Cavalier
mesh_terms: D000293:Adolescent; D000328:Adult; D002762:Cholecalciferol / Q000008:administration & dosage*; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy*; D014815:Vitamins / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D
keywords: randomized double-blind trial; safety; vitamin D