维生素 D 补充剂对糖尿病和慢性肾脏病成人的骨骼健康和生活质量的影响：一项开放标签随机临床试验的结果。
Vitamin D supplementation, bone health and quality of life in adults with diabetes and chronic kidney disease: Results of an open label randomized clinical trial.
机构信息
Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada; Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.
出版信息
Clin Nutr. 2017 Jun;36(3):686-696. doi: 10.1016/j.clnu.2016.05.012. Epub 2016 Jun 2.
BACKGROUND
Adults with diabetes (DM) and chronic kidney disease (CKD) are at risk for vitamin D (vitD) insufficiency, suboptimal bone health and reduced quality of life (QoL) due to limited sunlight exposure, poor vitD intake and CKD.
AIMS
This open-labeled, randomized clinical trial, compared the impact of daily (2000 IU/D) verses monthly (40,000 IU/month) vitD supplementation over six months on markers of vitD status, bone health and QoL in adults with DM and CKD (stages: 1-4).
METHODS
Participants (18-80 years) were randomized to daily (n = 60) or monthly (n = 60) vitD for six months. Primary outcomes included: vitD status (25-hydroxyvitD [25(OH)D], 1, 25-dihydroxyvitD [1,25(OH)D], bone health (bone mineral density [BMD] and serum concentrations of bone-specific alkaline phosphatase [BSAP], osteocalcin [OC], N-telopeptide-type 1-collagen [NTx]) and Fibroblast Growth Factor-23 (FGF-23). Secondary outcomes included QoL (Short Form-36 questionnaire).
RESULTS
Adherence by dose allocation over six months was 95.0 ± 5.7% (daily) and 94.1 ± 4.1% (monthly), respectively (p = 0.44); resulting in an overall median [95% CI] increase in serum 25(OH)D of 19 (12-26) nmol/L (p < 0.001). Serum 25(OH)D increased at three (p < 0.001) and six months (p < 0.001) in the daily and monthly groups, respectively. No significant differences over six months between groups were observed in serum concentrations of 1,25(OH)D, FGF-23, OC and NTx, BMD and QoL measures (p > 0.05). Serum 25(OH)D ≥ 75 nmol/L was associated with significant reductions in BSAP (p = 0.01) and improved physical functioning vs those with concentrations < 75 nmol/L (62.5 ± 26.8 vs 52.7 ± 26.3; p = 0.03) in the monthly and daily groups, respectively.
CONCLUSIONS
Daily (2000 IU/D) and monthly (40,000 IU/month) vitD supplementation for six months in adults with DM and CKD was safe, and resulted in equivalent adherence and improvements in overall vitD status, but only modest changes in markers of bone health and QoL.
背景
患有糖尿病（DM）和慢性肾脏病（CKD）的成年人由于阳光照射有限、维生素 D（vitD）摄入不足和 CKD，存在维生素 D 不足、骨骼健康状况不佳和生活质量（QoL）下降的风险。
目的
本开放性、随机临床试验比较了每日（2000IU/D）与每月（40,000IU/月）补充 vitD 六个月对 1-4 期 DM 和 CKD 成年人 vitD 状态、骨骼健康和 QoL 的影响。
方法
参与者（18-80 岁）被随机分为每日（n=60）或每月（n=60）vitD 组，治疗六个月。主要结局包括：vitD 状态（25-羟维生素 D [25（OH）D]、1,25-二羟维生素 D [1,25（OH）D]）、骨骼健康（骨密度 [BMD]和血清骨特异性碱性磷酸酶 [BSAP]、骨钙素 [OC]、N-端肽型 1 胶原 [NTx]）和成纤维细胞生长因子-23（FGF-23）。次要结局包括 QoL（36 项简短健康调查问卷）。
结果
六个月时按剂量分配的依从率分别为 95.0±5.7%（每日）和 94.1±4.1%（每月）（p=0.44）；血清 25（OH）D 中位数[95%CI]分别增加 19（12-26）nmol/L（p<0.001）。每日和每月组分别在三个月（p<0.001）和六个月（p<0.001）时血清 25（OH）D 升高。六个月时两组间血清 1,25（OH）D、FGF-23、OC 和 NTx、BMD 和 QoL 指标无显著差异（p>0.05）。血清 25（OH）D≥75nmol/L 与 BSAP 显著降低相关（p=0.01），与浓度<75nmol/L 的患者相比，每月和每日组的身体机能均有改善（62.5±26.8 比 52.7±26.3；p=0.03）。
结论
DM 和 CKD 成年人每日（2000IU/D）和每月（40,000IU/月）补充 vitD 六个月是安全的，且可实现等效的依从性，并改善整体 vitD 状态，但对骨骼健康和 QoL 标志物仅有适度影响。
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