Yu-Hui Zhang, Xiao Xu, Hai-Chen Pi, Zhi-Kai Yang, David W Johnson, Jie Dong
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Our objective is to examine the feasibility of conducting a large, randomised controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis.</p><p><strong>Design: </strong>Pilot, prospective, open-label randomised controlled trial.</p><p><strong>Setting: </strong>Peking University First Hospital, China.</p><p><strong>Participants: </strong>Patients receiving PD who had recovered from a recent episode of peritonitis between 30 September 2017 and 28 May 2020.</p><p><strong>Interventions: </strong>Oral natural vitamin D supplementation (2000 IU per day) versus no vitamin D supplementation for 12 months.</p><p><strong>Primary and secondary outcome measures: </strong>Primary outcomes were feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25(OH)D level during follow-up) for a large, randomised controlled trial in the future to determine the effects of vitamin D on PD-related peritonitis. Secondary outcomes were time to peritonitis occurrence and outcome of subsequent peritonitis.</p><p><strong>Results: </strong>Overall, 60 among 151 patients were recruited (recruitment rate was 39.7%, 95% CI 31.9-47.5%, recruitment rate among eligible patients was 61.9%, 95% CI 52.2-71.5%). Retention and adherence rates were 100.0% (95% CI 100.0-100.0%) and 81.5% (95% CI 66.8-96.1%), respectively. During follow-up, serum 25(OH)D levels increased in the vitamin D (VD) group (from 19.25 ± 10.11 nmol/L to 60.27 ± 23.29 nmol/L after 6 months, <i>p</i> < 0.001, <i>n</i> = 31), and remained higher (<i>p</i> < 0.001) than those in the control group (<i>n</i> = 29). No differences were observed between the two groups with respect to time to subsequent peritonitis (hazard ratio 0.85, 95% CI 0.33-2.17) or any of the peritonitis outcomes. Adverse events were uncommon.</p><p><strong>Conclusions: </strong>A randomised controlled trial of the effect of vitamin D supplementation on peritonitis occurrence in patients receiving PD is feasible, safe and results in adequate serum 25(OH)D levels.</p>","PeriodicalId":19969,"journal":{"name":"Peritoneal Dialysis International","volume":" ","pages":"27-36"},"PeriodicalIF":2.7000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: A pilot randomised controlled trial.\",\"authors\":\"Yu-Hui Zhang, Xiao Xu, Hai-Chen Pi, Zhi-Kai Yang, David W Johnson, Jie Dong\",\"doi\":\"10.1177/08968608231182885\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Peritoneal dialysis (PD)-related peritonitis is independently associated with low serum 25-hydroxy vitamin D [25(OH)D] levels. Our objective is to examine the feasibility of conducting a large, randomised controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis.</p><p><strong>Design: </strong>Pilot, prospective, open-label randomised controlled trial.</p><p><strong>Setting: </strong>Peking University First Hospital, China.</p><p><strong>Participants: </strong>Patients receiving PD who had recovered from a recent episode of peritonitis between 30 September 2017 and 28 May 2020.</p><p><strong>Interventions: </strong>Oral natural vitamin D supplementation (2000 IU per day) versus no vitamin D supplementation for 12 months.</p><p><strong>Primary and secondary outcome measures: </strong>Primary outcomes were feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25(OH)D level during follow-up) for a large, randomised controlled trial in the future to determine the effects of vitamin D on PD-related peritonitis. Secondary outcomes were time to peritonitis occurrence and outcome of subsequent peritonitis.</p><p><strong>Results: </strong>Overall, 60 among 151 patients were recruited (recruitment rate was 39.7%, 95% CI 31.9-47.5%, recruitment rate among eligible patients was 61.9%, 95% CI 52.2-71.5%). Retention and adherence rates were 100.0% (95% CI 100.0-100.0%) and 81.5% (95% CI 66.8-96.1%), respectively. During follow-up, serum 25(OH)D levels increased in the vitamin D (VD) group (from 19.25 ± 10.11 nmol/L to 60.27 ± 23.29 nmol/L after 6 months, <i>p</i> < 0.001, <i>n</i> = 31), and remained higher (<i>p</i> < 0.001) than those in the control group (<i>n</i> = 29). No differences were observed between the two groups with respect to time to subsequent peritonitis (hazard ratio 0.85, 95% CI 0.33-2.17) or any of the peritonitis outcomes. 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引用次数: 0
摘要
目的：腹膜透析（PD）相关腹膜炎与低血清25-羟基维生素D [25（OH）D]水平密切相关。我们的目标是研究开展大型随机对照试验的可行性，以确定补充维生素 D 对腹膜透析相关腹膜炎风险的影响：试点、前瞻性、开放标签随机对照试验：地点：中国北京大学第一医院：2017年9月30日至2020年5月28日期间接受腹膜透析治疗且近期腹膜炎痊愈的患者：口服天然维生素D补充剂（每天2000 IU）与12个月内不补充维生素D.主要和次要结局测量：主要结果为可行性（招募成功率、保留率、依从性、安全性）和忠实性（随访期间血清25（OH）D水平的变化），以便未来开展大型随机对照试验，确定维生素D对腹膜透析相关腹膜炎的影响。次要结果是腹膜炎发生的时间和后续腹膜炎的结果：总共招募了 151 名患者中的 60 名（招募率为 39.7%，95% CI 为 31.9-47.5%；符合条件的患者招募率为 61.9%，95% CI 为 52.2-71.5%）。保留率和坚持率分别为 100.0%（95% CI 100.0-100.0%）和 81.5%（95% CI 66.8-96.1%）。在随访期间，维生素 D（VD）组的血清 25（OH）D 水平有所上升（从 19.25 ± 10.11 nmol/L 升至 6 个月后的 60.27 ± 23.29 nmol/L，p < 0.001，n = 31），且仍高于对照组（n = 29）（p < 0.001）。两组患者发生腹膜炎的时间（危险比 0.85，95% CI 0.33-2.17）或腹膜炎的任何结果均无差异。不良事件并不常见：补充维生素 D 对腹膜透析患者腹膜炎发生率影响的随机对照试验是可行的、安全的，并能使血清 25(OH)D 水平达到足够的水平。
Oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: A pilot randomised controlled trial.
Objective: Peritoneal dialysis (PD)-related peritonitis is independently associated with low serum 25-hydroxy vitamin D [25(OH)D] levels. Our objective is to examine the feasibility of conducting a large, randomised controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis.
Participants: Patients receiving PD who had recovered from a recent episode of peritonitis between 30 September 2017 and 28 May 2020.
Interventions: Oral natural vitamin D supplementation (2000 IU per day) versus no vitamin D supplementation for 12 months.
Primary and secondary outcome measures: Primary outcomes were feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25(OH)D level during follow-up) for a large, randomised controlled trial in the future to determine the effects of vitamin D on PD-related peritonitis. Secondary outcomes were time to peritonitis occurrence and outcome of subsequent peritonitis.
Results: Overall, 60 among 151 patients were recruited (recruitment rate was 39.7%, 95% CI 31.9-47.5%, recruitment rate among eligible patients was 61.9%, 95% CI 52.2-71.5%). Retention and adherence rates were 100.0% (95% CI 100.0-100.0%) and 81.5% (95% CI 66.8-96.1%), respectively. During follow-up, serum 25(OH)D levels increased in the vitamin D (VD) group (from 19.25 ± 10.11 nmol/L to 60.27 ± 23.29 nmol/L after 6 months, p < 0.001, n = 31), and remained higher (p < 0.001) than those in the control group (n = 29). No differences were observed between the two groups with respect to time to subsequent peritonitis (hazard ratio 0.85, 95% CI 0.33-2.17) or any of the peritonitis outcomes. Adverse events were uncommon.
Conclusions: A randomised controlled trial of the effect of vitamin D supplementation on peritonitis occurrence in patients receiving PD is feasible, safe and results in adequate serum 25(OH)D levels.
期刊介绍：
Peritoneal Dialysis International (PDI) is an international publication dedicated to peritoneal dialysis. PDI welcomes original contributions dealing with all aspects of peritoneal dialysis from scientists working in the peritoneal dialysis field around the world.
Peritoneal Dialysis International is included in Index Medicus and indexed in Current Contents/Clinical Practice, the Science Citation Index, and Excerpta Medica (Nephrology/Urology Core Journal). It is also abstracted and indexed in Chemical Abstracts (CA), as well as being indexed in Embase as a priority journal.
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