高剂量胆钙化醇对正常受试者的影响：一项随机双盲、安慰剂对照试验。
Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial.
作者信息
Nygaard Birgitte, Frandsen Niels Erik, Brandi Lisbet, Rasmussen Knud, Oestergaard Ove Vyff, Oedum Lars, Hoeck Hans Christian, Hansen Ditte
机构信息
Department of Medicine, Roskilde University Hospital, Roskilde, Denmark.
Department of Clinical Biochemistry, Roskilde University Hospital, Roskilde, Denmark.
出版信息
PLoS One. 2014 Aug 28;9(8):e102965. doi: 10.1371/journal.pone.0102965. eCollection 2014.
BACKGROUND
Vitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects. The safety, especially concerning changes in urinary calcium excretion is of great importance.
METHODS
In a double-blinded, placebo-controlled study in 40 healthy volunteers, we examined the changes in mineral metabolism during supplementation with 3000 IU of oral cholecalciferol daily during 4 months.
RESULTS
Both 25(OH)vitamin D and 1,25(OH)2vitamin D increased significantly in the active treated group as compared to the placebo group (186% versus 14% (P<0.001) and 28% versus -8% (P<0.001)). No change was observed in urinary calcium excretion in the active group compared to the placebo group (P = 0.891). Fibroblast growth factor 23 increased significantly by 10% (P<0.018) in the active group. However, there was no difference in changes in FGF23 between treatment groups (P = 0.457).
CONCLUSION
High dose cholecalciferol significantly increases 25(OH)vitamin D and 1,25(OH)2vitamin D levels compared to placebo. No changes in urinary calcium excretion or other measured components of the mineral metabolism were found between groups.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00952562.
背景
通常建议患者和健康受试者大剂量补充维生素D。安全性，尤其是与尿钙排泄变化相关的安全性非常重要。
方法
在一项针对40名健康志愿者的双盲、安慰剂对照研究中，我们检测了4个月期间每日口服3000 IU胆钙化醇补充剂时矿物质代谢的变化。
结果
与安慰剂组相比，活性治疗组的25(OH)维生素D和1,25(OH)2维生素D均显著升高（分别为186%对14%，P<0.001；28%对 -8%，P<0.001）。与安慰剂组相比，活性组的尿钙排泄无变化（P = 0.891）。活性组中成纤维细胞生长因子23显著升高10%（P<0.018）。然而，治疗组之间FGF23的变化无差异（P = 0.457）。
结论
与安慰剂相比，高剂量胆钙化醇显著提高了25(OH)维生素D和1,25(OH)2维生素D水平。两组之间未发现尿钙排泄或矿物质代谢的其他测量成分有变化。
试验注册
ClinicalTrials.gov NCT00952562。
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