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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

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Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège B-4000, Belgium
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Laboratoire d'Explorations fonctionnelles, Hôpital Necker-Enfants malades, Paris 75015, France
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Department of Clinical Pharmacology, ATC SA, Liège B-4000, Belgium
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Clinical Department, Laboratoires SMB SA, Brussels 1080, Belgium
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Division of Diabetes, Nutrition and Metabolic Disorders, CHU Sart Tilman, University of Liège, Liège B-4000, Belgium
*
Author to whom correspondence should be addressed.
Nutrients 2015, 7(7), 5413-5422; https://doi.org/10.3390/nu7075227
Received: 9 April 2015 / Revised: 10 June 2015 / Accepted: 23 June 2015 / Published: 3 July 2015
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. View Full-Text
Keywords: vitamin D; randomized double-blind trial; safety vitamin D; randomized double-blind trial; safety
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Schleck, M.-L.; Souberbielle, J.-C.; Jandrain, B.; Da Silva, S.; De Niet, S.; Vanderbist, F.; Scheen, A.; Cavalier, E. 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. Nutrients 2015, 7, 5413-5422.

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