Bruyère O, Deroisy R, Dardenne N, Cavalier E, Coffiner M, Da Silva S, De Niet S, Reginster J-Y
Support Unit in Epidemiology and Biostatistics, Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, 4000, Belgium.
Médecine Appareil Locomoteur, CHU Liège, BRULL, Liège, Belgium.
Osteoporos Int. 2015 Dec;26(12):2863-8. doi: 10.1007/s00198-015-3205-z. Epub 2015 Jun 23.
In a randomized, cross-over study, once monthly administration of vitamin D3 was preferred over a once daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels.
The aim of the present study was to compare a once-monthly administration of vitamin D3 to a daily administration of a fixed-dose combination of vitamin D3 and calcium during two treatment periods of 6 months.
One hundred volunteers aged 50 years old or older were randomized to receive either one drinkable ampoule containing 25,000 IU vitamin D3 (D-Cure®, SMB) once monthly (group VD) or one chewable tablet containing 1000 mg calcium carbonate + 800 IU vitamin D3 (Steovit Forte®, Takeda) once daily (group VDCa) during 6 months. After the first 6 months of treatment, the groups were reversed according to the randomized cross-over design. Treatment compliance (i.e. the primary outcome), preference, acceptability and vitamin D levels and adverse events were all collected.
For the two periods, the patients had a significantly higher compliance in the VD group than in the VDCa group (p < 0.0001). During the study, 50 (56.8 %) patients preferred the VD treatment, 16 (18.2 %) patients preferred the VDCa, and for 22 (25.0 %) patients, neither treatment was preferred. At the end of the first 6 months of treatment, the mean (SD) increase of 25(OH)D was 6.57 ng/mL (8.19) in the VD group and 3.88 ng/mL (10.0) in the VDCa group (p = 0.16 between groups).
In this study, a once-monthly administration of vitamin D3 was preferred over a once-daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels.
在一项随机交叉研究中，每月一次服用维生素D3比每日服用固定剂量的维生素D3和钙的组合更受青睐，前者依从性更好，但维生素D水平升高方面无显著差异。
本研究的目的是在两个为期6个月的治疗期内，比较每月一次服用维生素D3与每日服用固定剂量的维生素D3和钙的组合。
100名50岁及以上的志愿者被随机分为两组，一组每月服用一支含25,000 IU维生素D3的可饮用安瓿剂（D-Cure®，SMB）（VD组），另一组每日服用一片含1000 mg碳酸钙 + 800 IU维生素D3的咀嚼片（Steovit Forte®，武田）（VDCa组），为期6个月。在第一个6个月的治疗期结束后，根据随机交叉设计两组进行互换。收集治疗依从性（即主要结局）、偏好、可接受性、维生素D水平和不良事件。
在两个治疗期内，VD组患者的依从性显著高于VDCa组（p < 0.0001）。在研究期间，50名（56.8%）患者更喜欢VD治疗，16名（18.2%）患者更喜欢VDCa治疗，22名（25.0%）患者对两种治疗均无偏好。在第一个6个月治疗期结束时，VD组25(OH)D的平均（标准差）升高为6.57 ng/mL（8.19），VDCa组为3.88 ng/mL（10.0）（两组间p = 0.16）。
在本研究中，每月一次服用维生素D3比每日服用固定剂量的维生素D3和钙的组合更受青睐，前者依从性更好，但维生素D水平升高方面无显著差异。
