每月大剂量维生素 D3 补充剂和 4 年随机对照试验中的自我报告不良事件。

Monthly high-dose vitamin D3 supplementation and self-reported adverse events in a 4-year randomized controlled trial.

机构信息

School of Population Health, University of Auckland, Auckland, New Zealand.

Department of General Practice, University of Otago, Christchurch, New Zealand.

出版信息

Clin Nutr. 2019 Aug;38(4):1581-1587. doi: 10.1016/j.clnu.2018.07.034. Epub 2018 Aug 4.

DOI:10.1016/j.clnu.2018.07.034

PMID:30146166

Abstract

BACKGROUND

The use of high-dose vitamin D supplementation has increased in recent years. However, relatively little is known about the safety of long-term high doses.

AIMS

To investigate the safety of a monthly high-dose of vitamin D supplementation taken for up to 4 years.

METHODS

Data were collected in a randomized, double blind, placebo-controlled trial of 5108 adults aged 50-84 years old from Auckland, New Zealand. Participants were given monthly doses of 100,000 IU vitamin D or placebo, for a median of 3.3 years (range 2.5-4.2 years). They answered an open-ended question in a monthly questionnaire about any adverse events they attributed to the study capsules, which were coded blindly. Incidence rates per person months were calculated for categories of adverse events. Cox regression model used to calculate hazard ratio of time to first adverse-event.

RESULTS

In total, 419 (16.5%) participants taking vitamin D and 399 (15.8%) taking placebo reported ≥1 adverse event. Compared to placebo, the hazard ratio (HR) of reporting first adverse event in the vitamin D group was 1.03 (95% CI: 0.90, 1.18; p = 0.63). Despite a slightly higher incidence of recurrent adverse events in vitamin D arm, the incidence rate ratio (1.17) was not significantly higher in vitamin D (95% CI: 0.97, 1.41; p = 0.10). All regression results were adjusted for age, sex, and ethnicity. There was no difference between study arms in terms of participants' allocation perception (p = 0.52).

CONCLUSION

Monthly supplementation of 100,000 IU vitamin D3 for a median of 3.3 years did not affect participant-reported adverse events.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: ACTRN12611000402943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12611000402943.

摘要

背景

近年来，高剂量维生素 D 补充剂的使用有所增加。然而，关于长期大剂量使用的安全性知之甚少。

目的

研究长达 4 年的每月高剂量维生素 D 补充的安全性。

方法

这项来自新西兰奥克兰的 5108 名 50-84 岁成年人的随机、双盲、安慰剂对照试验中收集了数据。参与者每月接受 100000IU 维生素 D 或安慰剂治疗，中位时间为 3.3 年（范围 2.5-4.2 年）。他们在每月的问卷中回答了一个关于他们认为与研究胶囊有关的任何不良事件的开放式问题，这些问题是盲法编码的。按不良事件类别计算每人数月的发生率。使用 Cox 回归模型计算首次不良事件发生时间的风险比。

结果

共有 419 名（16.5%）服用维生素 D 的参与者和 399 名（15.8%）服用安慰剂的参与者报告了≥1 次不良事件。与安慰剂相比，维生素 D 组报告首次不良事件的风险比（HR）为 1.03（95%CI：0.90，1.18；p=0.63）。尽管维生素 D 组的复发性不良事件发生率略高，但维生素 D 组的发生率比值（1.17）并没有显著更高（95%CI：0.97，1.41；p=0.10）。所有回归结果均按年龄、性别和种族进行了调整。在参与者对研究分配的认知方面，两组之间没有差异（p=0.52）。