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

• Published in: Nutrients Vol. 7; no. 7; pp. 5413 - 5422
• Main Authors: Schleck, Marie-Louise, Souberbielle, Jean-Claude, Jandrain, Bernard, Da Silva, Stéphanie, De Niet, Sophie, Vanderbist, Francis, Scheen, André, Cavalier, Etienne
• Format: Journal Article Web Resource
• Language: English
• Published: Switzerland MDPI AG 03.07.2015; Molecular Diversity Preservation International (MDPI); MDPI
• Subjects: Adolescent; Adult; Cholecalciferol - administration & dosage; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Human health sciences; Humans; Laboratory medicine & medical technology; Male; Middle Aged; Médecine de laboratoire & technologie médicale; Patients; randomized double-blind trial; safety; Sciences de la santé humaine; Vitamin D; Vitamin D - analogs & derivatives; Vitamin D - blood; Vitamin D Deficiency - blood; Vitamin D Deficiency - drug therapy; Vitamin deficiency; Vitamins - administration & dosage; Young Adult; Belgium; safety; vitamin D; randomized double-blind trial
• ISSN: 2072-6643; 2072-6643
• DOI: 10.3390/nu7075227

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.