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Nutrients 2015, 7(7), 5413-5422; doi:10.3390/nu7075227

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

1
Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège B-4000, Belgium
2
Laboratoire d'Explorations fonctionnelles, Hôpital Necker-Enfants malades, Paris 75015, France
3
Department of Clinical Pharmacology, ATC SA, Liège B-4000, Belgium
4
Clinical Department, Laboratoires SMB SA, Brussels 1080, Belgium
5
Division of Diabetes, Nutrition and Metabolic Disorders, CHU Sart Tilman, University of Liège, Liège B-4000, Belgium
*
Author to whom correspondence should be addressed.
Received: 9 April 2015 / Revised: 10 June 2015 / Accepted: 23 June 2015 / Published: 3 July 2015
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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. View Full-Text
Keywords: vitamin D; randomized double-blind trial; safety vitamin D; randomized double-blind trial; safety
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

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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