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Effect of High-Dose Vitamin D Supplementation on Volumetric Bone Density and Bone Strength
JAMA ( IF 120.7 ) Pub Date : 2019-08-27 , DOI: 10.1001/jama.2019.11889
Lauren A Burt 1 , Emma O Billington 1 , Marianne S Rose 2 , Duncan A Raymond 1 , David A Hanley 1 , Steven K Boyd 1
Affiliation  

Importance Few studies have assessed the effects of daily vitamin D doses at or above the tolerable upper intake level for 12 months or greater, yet 3% of US adults report vitamin D intakes of at least 4000 IU per day. Objective To assess the dose-dependent effect of vitamin D supplementation on volumetric bone mineral density (BMD) and strength. Design, Setting, and Participants Three-year, double-blind, randomized clinical trial conducted in a single center in Calgary, Canada, from August 2013 to December 2017, including 311 community-dwelling healthy adults without osteoporosis, aged 55 to 70 years, with baseline levels of 25-hydroxyvitamin D (25[OH]D) of 30 to 125 nmol/L. Interventions Daily doses of vitamin D3 for 3 years at 400 IU (n = 109), 4000 IU (n = 100), or 10 000 IU (n = 102). Calcium supplementation was provided to participants with dietary intake of less than 1200 mg per day. Main Outcomes and Measures Co-primary outcomes were total volumetric BMD at radius and tibia, assessed with high resolution peripheral quantitative computed tomography, and bone strength (failure load) at radius and tibia estimated by finite element analysis. Results Of 311 participants who were randomized (53% men; mean [SD] age, 62.2 [4.2] years), 287 (92%) completed the study. Baseline, 3-month, and 3-year levels of 25(OH)D were 76.3, 76.7, and 77.4 nmol/L for the 400-IU group; 81.3, 115.3, and 132.2 for the 4000-IU group; and 78.4, 188.0, and 144.4 for the 10 000-IU group. There were significant group × time interactions for volumetric BMD. At trial end, radial volumetric BMD was lower for the 4000 IU group (-3.9 mg HA/cm3 [95% CI, -6.5 to -1.3]) and 10 000 IU group (-7.5 mg HA/cm3 [95% CI, -10.1 to -5.0]) compared with the 400 IU group with mean percent change in volumetric BMD of -1.2% (400 IU group), -2.4% (4000 IU group), and -3.5% (10 000 IU group). Tibial volumetric BMD differences from the 400 IU group were -1.8 mg HA/cm3 (95% CI, -3.7 to 0.1) in the 4000 IU group and -4.1 mg HA/cm3 in the 10 000 IU group (95% CI, -6.0 to -2.2), with mean percent change values of -0.4% (400 IU), -1.0% (4000 IU), and -1.7% (10 000 IU). There were no significant differences for changes in failure load (radius, P = .06; tibia, P = .12). Conclusions and Relevance Among healthy adults, treatment with vitamin D for 3 years at a dose of 4000 IU per day or 10 000 IU per day, compared with 400 IU per day, resulted in statistically significant lower radial BMD; tibial BMD was significantly lower only with the 10 000 IU per day dose. There were no significant differences in bone strength at either the radius or tibia. These findings do not support a benefit of high-dose vitamin D supplementation for bone health; further research would be needed to determine whether it is harmful. Trial Registration ClinicalTrials.gov Identifier: NCT01900860.

中文翻译:

高剂量维生素 D 补充剂对体积骨密度和骨强度的影响

重要性 很少有研究评估在 12 个月或更长时间内每日维生素 D 剂量等于或高于可耐受的上限摄入量的影响,但 3% 的美国成年人报告每天至少 4000 IU 的维生素 D 摄入量。目的评估补充维生素 D 对体积骨矿物质密度 (BMD) 和强度的剂量依赖性影响。设计、设置和参与者 2013 年 8 月至 2017 年 12 月在加拿大卡尔加里的一个单一中心进行的为期三年、双盲、随机的临床试验,包括 311 名年龄在 55 至 70 岁、没有骨质疏松症的社区健康成年人, 25-羟基维生素 D (25[OH]D) 的基线水平为 30 至 125 nmol/L。干预 3 年中维生素 D3 的每日剂量为 400 IU(n = 109)、4000 IU(n = 100)或 10 000 IU(n = 102)。为每日膳食摄入量低于 1200 毫克的参与者提供钙补充剂。主要结果和测量 共同主要结果是桡骨和胫骨的总体积 BMD,用高分辨率外周定量计算机断层扫描评估,以及通过有限元分析估计的桡骨和胫骨的骨强度(失效负荷)。结果 在随机分配的 311 名参与者(53% 男性;平均 [SD] 年龄,62.2 [4.2] 岁)中,287 名 (92%) 完成了研究。400-IU 组的基线、3 个月和 3 年 25(OH)D 水平分别为 76.3、76.7 和 77.4 nmol/L;4000-IU 组为 81.3、115.3 和 132.2;10 000-IU 组为 78.4、188.0 和 144.4。体积 BMD 存在显着的组×时间交互作用。在试验结束时,4000 IU 组的径向体积 BMD 较低(-3.9 mg HA/cm3 [95% CI,-6. 5 至 -1.3])和 10 000 IU 组(-7.5 mg HA/cm3 [95% CI,-10.1 至 -5.0])与 400 IU 组相比,体积 BMD 的平均变化百分比为 -1.2%(400 IU组)、-2.4%(4000 IU 组)和-3.5%(10 000 IU 组)。与 400 IU 组相比,4000 IU 组的胫骨体积 BMD 差异为 -1.8 mg HA/cm3(95% CI,-3.7 至 0.1),10 000 IU 组为 -4.1 mg HA/cm3(95% CI,- 6.0 至 -2.2),平均百分比变化值为 -0.4% (400 IU)、-1.0% (4000 IU) 和 -1.7% (10 000 IU)。失效载荷的变化没有显着差异(半径,P = .06;胫骨,P = .12)。结论和相关性 在健康成人中,以每天 4000 IU 或每天 10 000 IU 的剂量使用维生素 D 治疗 3 年,与每天 400 IU 相比,导致径向 BMD 显着降低;仅在每天 10 000 IU 剂量下,胫骨 BMD 显着降低。桡骨或胫骨的骨强度没有显着差异。这些发现不支持补充高剂量维生素 D 对骨骼健康有益;需要进一步研究以确定它是否有害。试验注册 ClinicalTrials.gov 标识符:NCT01900860。
更新日期:2019-08-27
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