Hoeck H C, Li B, Qvist P
Center for Clinical and Basic Research, 9000 Aalborg, Denmark.
Osteoporos Int. 2009 Aug;20(8):1329-35. doi: 10.1007/s00198-008-0790-0. Epub 2008 Dec 13.
This study reports on oral treatment with different doses of vitamin D3 ranging from 25 to 200 microg in females with 25-hydroxyvitamin D3 levels < 60 nmol/L screened for participation in an osteoporosis trial. A guidance to safely and efficiently achieve 25-hydroxyvitamin D3 levels > 60 nmol/L is presented.
The importance of vitamin D for skeletal health has been implemented in clinical trials in osteoporosis. The threshold of 25-hydroxyvitamin D for inclusion has changed from 30 to 60 nmol/L. This study reports on oral treatment with different doses of vitamin D3 in females with 25-hydroxyvitamin D3 levels < 60 nmol/L.
In 131 postmenopausal females screened for participation in an osteoporosis trial, the 25-hydroxyvitamin D3 concentration was < 60 nmol/L. They were treated with 25 (n = 22), 50 (n = 19), 75 (n = 19), 100 (n = 41) or 200 microg (n = 30) of vitamin D3 daily for at least 10 days.
In the females treated with 25, 50, 75, 100 and 200 microg of vitamin D3 daily the 25-hydroxyvitamin D3 concentrations increased significantly from 32.4 +/- 2.7 (mean +/- SEM) to 50.8 +/- 2.9, from 46.7 +/- 2.8 to 65.8 +/- 2.6, from 41.6 +/- 2.7 to 67.4 +/- 2.9, from 46.7 +/- 1.4 to 64.4 +/- 2.2 and from 42.1 +/- 2.0 to 71.2 +/- 2.8 nmol/L, respectively (p < 0.001). S-calcium increased significantly but within the reference range (p < 0.006).
Oral vitamin D3 safely increased 25-hydroxyvitamin D3 concentrations in all females above 60 nmol/L. This study demonstrates how to achieve the new recommended 25-hydroxyvitamin D concentrations within the screening period of a clinical trial.
本研究报告了对25-羟维生素D3水平<60 nmol/L的女性口服不同剂量（25至200微克）维生素D3的情况，这些女性是为参与一项骨质疏松症试验而筛选的。本文给出了安全有效地使25-羟维生素D3水平>60 nmol/L的指导建议。
维生素D对骨骼健康的重要性已在骨质疏松症的临床试验中得到体现。纳入标准中25-羟维生素D的阈值已从30 nmol/L变为60 nmol/L。本研究报告了对25-羟维生素D3水平<60 nmol/L的女性口服不同剂量维生素D3的情况。
在131名筛选参与骨质疏松症试验的绝经后女性中，25-羟维生素D3浓度<60 nmol/L。她们分别接受每日25（n = 22）、50（n = 19）、75（n = 19）、100（n = 41）或200微克（n = 30）维生素D3的治疗，持续至少10天。
在每日接受25、50、75、100和200微克维生素D3治疗的女性中，25-羟维生素D3浓度分别从32.4±2.7（均值±标准误）显著升至50.8±2.9、从46.7±2.8升至65.8±2.6、从41.6±2.7升至67.4±2.9、从46.7±1.4升至64.4±2.2以及从42.1±2.0升至71.2±2.8 nmol/L（p<0.001）。血清钙显著升高，但在参考范围内（p<0.006）。
口服维生素D3可使所有女性的25-羟维生素D3浓度安全升至60 nmol/L以上。本研究展示了如何在临床试验的筛选期内达到新推荐的25-羟维生素D浓度。
