Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
Faculty of Health, University of Tasmania, Hobart, Tasmania, Australia.
Eur J Clin Nutr. 2018 Apr;72(4):534-540. doi: 10.1038/s41430-018-0098-x. Epub 2018 Jan 26.
BACKGROUND/OBJECTIVES: Vitamin D deficiency is common in adolescents but the optimal dosage regimen for correcting deficiency is unknown. To test the safety and efficacy of two different vitamin D dosage regimens to correct vitamin D deficiency in adolescents.
SUBJECTS/METHODS: In this 12-month, double-blind, randomized placebo-controlled trial, 28 adolescents (serum 25 hydroxyvitamin D (25(OH)D) of 21 to 50 nmol/L) were randomly assigned to one of three groups: monthly (n = 9; vitamin D3 50,000 IU orally monthly plus three placebo tablets 3-monthly), 3-monthly (n = 9; 150,000 IU (3 × 50,000 IU tablets) 3-monthly and placebo orally monthly), or placebo (n = 10; placebo monthly and three placebo tablets 3-monthly). Serum 25(OH)D was measured at baseline, 3, 6 and 12 months.
Two participants withdrew after their baseline measurement from the 3-monthly group. At 12 months, one participant was deficient (≤50 nmol/L) in both the monthly and 3-monthly groups, whereas six out of ten in the placebo remained deficient (P = 0.055). At 12 months, the average serum 25(OH)D levels for the monthly, 3-monthly and placebo groups were 76.4, 64.7 and 49.7 nmol/L, respectively (P < 0.001 and P = 0.04 for differences between monthly and placebo groups and 3-monthly and placebo groups respectively, after adjustment for age, sex and seasonal variation). Adherence was 100% and adverse events were minor.
Both 50,000 IU monthly and 150,000 IU 3-monthly of vitamin D3 safely and effectively corrects vitamin D deficiency in adolescents. These data provide treatment options which can be used by health practitioners to tailor vitamin D dosage regiments according to patient preference and context.
背景/目的：青少年中维生素 D 缺乏很常见，但纠正缺乏的最佳剂量方案尚不清楚。本研究旨在检验两种不同维生素 D 剂量方案治疗青少年维生素 D 缺乏的安全性和疗效。
受试者/方法：这是一项为期 12 个月的、双盲、随机安慰剂对照试验，共纳入 28 名血清 25 羟维生素 D（25(OH)D）水平为 21-50nmol/L 的青少年，随机分为三组：每月组（n=9；每月口服 50,000IU 维生素 D3 一次和 3 个月 3 片安慰剂）、每 3 个月组（n=9；每 3 个月口服 150,000IU[3×50,000IU 片剂]一次和每月口服安慰剂）和安慰剂组（n=10；每月口服安慰剂和每 3 个月口服 3 片安慰剂）。在基线、3、6 和 12 个月时检测血清 25(OH)D。
有 2 名参与者在每 3 个月组的基线测量后退出研究。12 个月时，每月组和每 3 个月组各有 1 名参与者仍存在维生素 D 缺乏（≤50nmol/L），而安慰剂组中仍有 6 名参与者缺乏（P=0.055）。12 个月时，每月组、每 3 个月组和安慰剂组的平均血清 25(OH)D 水平分别为 76.4、64.7 和 49.7nmol/L（调整年龄、性别和季节性变化后，每月组和安慰剂组以及每 3 个月组和安慰剂组之间的差异有统计学意义，P<0.001 和 P=0.04）。药物依从性为 100%，不良事件轻微。
每月 50,000IU 和每 3 个月 150,000IU 的维生素 D3 均安全有效地纠正了青少年的维生素 D 缺乏。这些数据为临床医生提供了治疗选择，可以根据患者的偏好和具体情况调整维生素 D 剂量方案。
