A dose-response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial

A dose-response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial
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DOI:
10.1007/s00394-015-0859-4
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发表时间:
2016-02-01
影响因子:
5
通讯作者:
Lin, Xu
Lin, Xu
中科院分区:
医学2区
文献类型:
--
作者:
Yao, Pang;Lu, Ling;Lin, Xu

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为研究维生素D3对中国成年人血清25-羟维生素D [25(OH)D]的影响,采用5组、随机、双盲、平行对照的方法,将76名健康受试者分为4组,分别口服0、400、800、1200和2000 IU/d的维生素D3,共16周。在多个时间点测量血清25(OH)D、甲状旁腺激素、钙、肝和肾功能的生物标志物。基线时的平均(SD)血清25(OH)D为31.6(8.7)nmol/L,所有剂量的剂量-反应关系均为曲线,在6周左右达到平台。在第16周,25(OH)D增加了6.0(6.5)、21.7(15.8)、26.3(12.6)、32.0(12.8)和36.3(26.0)nmol/L,0、400、800、1200和2000 IU/d(所有的Pa千分之一货币符号0.002),分别对应于维生素D缺乏的恢复的大约19、53、67、77和80%。每日摄入800 IU维生素D3至少有97.5%的中国人达到了目标25(OH)D a千分之30 nmol/L,但即使2000 IU/d也没有达到目标25(OH)D a千分之50 nmol/L。在控制年龄和性别后,25(OH)D变化与PTH变化呈负相关(r =-0.39,P < 0.001)。血清钙、谷丙转氨酶、谷草转氨酶、γ-谷氨酰转移酶和肌酐的变化无显著性差异(P <0.22),补充400、800、1200和2000 IU/d的维生素D可不同程度地改善维生素D缺乏症。2000 IU/d的维生素D3是否会产生更好的结果而没有副作用,需要更多的研究和更大的样本在未来。
To determine the dose-response of vitamin D3 supplementation on serum 25-hydroxyvitamin D [25(OH)D] among Chinese adults.In this 5-arm, randomized, double-blinded controlled trial, 76 healthy participants were assigned to orally administrate 0, 400, 800, 1200 or 2000 IU/d of vitamin D3 for 16 weeks. Serum 25(OH)D, parathyroid hormone, calcium, biomarkers of liver and renal function were measured at multiple time points.The mean (SD) serum 25(OH)D at baseline was 31.6 (8.7) nmol/L, and the dose-response relationship was curvilinear with a plateau around 6 weeks for all doses. At week 16, 25(OH)D was increased by 6.0 (6.5), 21.7 (15.8), 26.3 (12.6), 32.0 (12.8) and 36.3 (26.0) nmol/L for 0, 400, 800, 1200 and 2000 IU/d (all P a parts per thousand currency sign 0.002), corresponding to approximately 19, 53, 67, 77 and 80 % of reversion of vitamin D deficiency, respectively. Daily intake of 800 IU vitamin D3 reached a targeted 25(OH)D a parts per thousand yen 30 nmol/L in at least 97.5 % of Chinese, but not a targeted 25(OH)D a parts per thousand yen 50 nmol/L even with 2000 IU/d. Change of 25(OH)D was inversely associated with change of PTH concentration (r = -0.39, P < 0.001) after controlling for age and sex. No between-group differences were observed in terms of the change in serum calcium, alanine transaminase, aspartate aminotransferase, gamma-glutamyltransferase and creatinine (P a parts per thousand yen 0.22).Supplementation with 400, 800, 1200 or 2000 IU/d vitamin D could improve the vitamin D deficiency with various degrees. Whether 2000 IU/d vitamin D3 would generate a better result without side effect requires more studies with larger samples in future.