Active vitamin D treatment in the prevention of sarcopenia in adults with prediabetes (DPVD ancillary study): a randomised controlled trial

IF 13.4 Q1 GERIATRICS & GERONTOLOGY Lancet Healthy Longevity Pub Date : 2024-03-01 DOI:10.1016/S2666-7568(24)00009-6

Tetsuya Kawahara MD , Prof Gen Suzuki MD , Shoichi Mizuno PhD , Naoki Tominaga MD , Mikio Toda MD , Nagahiro Toyama MD , Prof Tetsuya Inazu MD , Chie Kawahara MD , Yosuke Okada MD , Prof Yoshiya Tanaka MD

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Abstract

Background

Observational studies show inverse associations between serum 25-hydroxyvitamin D concentrations and sarcopenia incidence; however, it remains unclear whether treatment with vitamin D prevents its development. We aimed to assess whether treatment with active vitamin D (eldecalcitol [0·75 μg per day]) can reduce the development of sarcopenia among adults with prediabetes.

Methods

This randomised, double-blind, placebo-controlled, multicenter trial as an ancillary study was conducted at 32 clinics and hospital sites in Japan. Participants were assigned (1:1) by using a central randomisation method in which a randomisation list was made for each hospital separately using a stratified permuted block procedure. The primary endpoint was sarcopenia incidence during 3 years in the intention-to-treat population defined as weak handgrip strength (<28 kg for men and <18 kg for women) and low appendicular skeletal muscle index (<7·0 kg/m² for men and <5·7 kg/m² for women in bioelectrical impedance analysis). Although the usual criterion of hypercalcaemia was 10·4 mg/dL (2·6 mmol/L) or higher, hypercalcaemia that was enough to discontinue the study was defined as 11·0 mg/dL or higher. This study is registered with the UMIN clinical trials registry, UMIN000005394.

Findings

A total of 1094 participants (548 in the eldecalcitol group and 546 in the placebo group; 44·2% [484 of 1094] women; mean age 60·8 [SD 9·2] years) were followed up for a median of 2·9 (IQR 2·8–3·0) years. Eldecalcitol treatment as compared with placebo showed statistically significant preventive effect on sarcopenia incidence (25 [4·6%] of 548 participants in the eldecalcitol group and 48 [8·8%] of 546 participants in the placebo group; hazard ratio 0·51; 95% CI 0·31 to 0·83; p=0·0065). The incidence of adverse events did not differ between the two groups.

Interpretation

We found that treatment with eldecalcitol has the potential to prevent the onset of sarcopenia among people with prediabetes via increasing skeletal muscle volume and strength, which might lead to a substantial risk reduction of falls.

Funding

Kitakyushu Medical Association.

Translation

For the Japanese translation of the abstract see Supplementary Materials section.

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预防糖尿病前期成人肌肉疏松症的活性维生素 D 治疗（DPVD 辅助研究）：随机对照试验。

背景：观察性研究显示，血清中 25- 羟基维生素 D 的浓度与肌肉疏松症的发病率呈反向关系；然而，目前仍不清楚维生素 D 治疗是否能预防肌肉疏松症的发生。我们旨在评估活性维生素 D（艾地骨化醇[每天 0-75 μg]）的治疗能否减少糖尿病前期成人肌肉疏松症的发生：这项随机、双盲、安慰剂对照、多中心试验作为辅助研究在日本 32 家诊所和医院进行。参与者的分配（1:1）采用中央随机法，即通过分层包块程序为每家医院分别制定随机名单。主要终点是意向治疗人群中三年内肌肉疏松症的发生率，定义为手部握力减弱（在生物电阻抗分析中，男性为2次，女性为2次）。虽然高钙血症的通常标准是 10-4 毫克/分升（2-6 毫摩尔/升）或更高，但足以终止研究的高钙血症定义为 11-0 毫克/分升或更高。该研究已在 UMIN 临床试验注册中心注册，注册号为 UMIN000005394：共有 1094 名参与者（548 人在艾地骨化醇组，546 人在安慰剂组；44-2% [1094 人中有 484 名] 女性；平均年龄 60-8 [SD 9-2] 岁）接受了中位数为 2-9 (IQR 2-8-3-0) 年的随访。与安慰剂相比，艾地骨化醇治疗对预防肌少症的发生有显著的统计学作用（艾地骨化醇组 548 名参与者中有 25 [4-6%] 人，安慰剂组 546 名参与者中有 48 [8-8%] 人；危险比为 0-51；95% CI 为 0-31 至 0-83；P=0-0065）。两组的不良反应发生率没有差异：我们发现，使用老年骨化醇治疗可通过增加骨骼肌体积和力量来预防糖尿病前期患者出现肌肉疏松症，从而大大降低跌倒风险：北九州医疗协会：摘要的日语翻译见补充材料部分。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lancet Healthy Longevity GERIATRICS & GERONTOLOGY-

CiteScore

16.30

自引率

2.30%

发文量

192

审稿时长

12 weeks

期刊介绍： The Lancet Healthy Longevity, a gold open-access journal, focuses on clinically-relevant longevity and healthy aging research. It covers early-stage clinical research on aging mechanisms, epidemiological studies, and societal research on changing populations. The journal includes clinical trials across disciplines, particularly in gerontology and age-specific clinical guidelines. In line with the Lancet family tradition, it advocates for the rights of all to healthy lives, emphasizing original research likely to impact clinical practice or thinking. Clinical and policy reviews also contribute to shaping the discourse in this rapidly growing discipline.