The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial

Abstract Background: Vitamin D deficiency has been shown to be closely associated with peritoneal dialysis (PD)-related peritonitis. The aim of this study is to examine the feasibility of conducting a large, powered randomized controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis in patients who have already experienced an episode of peritonitis. Methods: This prospective, open-label randomized controlled pilot trial with blinded end-points (PROBE) aims to determine the feasibility of oral vitamin D supplementation and to explore its effects on the risk of subsequent PD-related peritonitis among PD patients who have recovered from a recent episode of peritonitis. Eligible patients will be randomized 1:1 to either oral vitamin D supplementation (2000 IU per day; intervention group) or no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis (ISPD) Guidelines. The sample size will be 30 for both groups. All participants will be followed for 12 months. The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxy vitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future. Secondary outcomes include time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30 days of peritonitis onset). Discussion: This is the first randomized controlled trail investigating the effects of vitamin D supplementation on the risk of subsequent PD-related peritonitis among patients on PD. The findings for this pilot study will determine the feasibility of conducting a full-scale randomized controlled trail, which may provide a new strategy for preventing PD-related peritonitis among PD patients. Trial registration: Clinicaltrails.gov, NCT03264625, registered on 29 August 2017. https://www.clinicaltrials.gov/ct2/show/NCT03264625?term=NCT 03264625&rank=1, assessed on 1 July 2019.

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The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial

10.21203/rs.2.12622/v2 ◽

2019 ◽

Author(s):

Yuhui Zhang ◽

Xiao Xu ◽

Haichen Pi ◽

Zhikai Yang ◽

David W Johnson ◽

...

Keyword(s):

Vitamin D ◽

Randomized Controlled Trial ◽

Peritoneal Dialysis ◽

Controlled Trial ◽

Pilot Trial ◽

Vitamin D Supplementation ◽

Control Group ◽

Oral Vitamin ◽

Randomized Controlled ◽

Randomized Controlled Trail

Abstract Background: Vitamin D deficiency has been shown to be closely associated with peritoneal dialysis (PD)-related peritonitis. The aim of this study is to examine the feasibility of conducting a large, powered randomized controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis in patients who have already experienced an episode of peritonitis. Methods: This prospective, open-label randomized controlled pilot trial with blinded end-points (PROBE) aims to determine the feasibility of oral vitamin D supplementation and to explore its effects on the risk of subsequent PD-related peritonitis among PD patients who have recovered from a recent episode of peritonitis. Eligible patients will be randomized 1:1 to either oral vitamin D supplementation (2000 IU per day; intervention group) or no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis (ISPD) Guidelines. The sample size will be 30 for both groups. All participants will be followed for 12 months. The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxy vitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future. Secondary outcomes include time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30 days of peritonitis onset). Discussion: This is the first randomized controlled trail investigating the effects of vitamin D supplementation on the risk of subsequent PD-related peritonitis among patients on PD. The findings for this pilot study will determine the feasibility of conducting a full-scale randomized controlled trail, which may provide a new strategy for preventing PD-related peritonitis among PD patients. Trial registration: Clinicaltrails.gov, NCT03264625, registered on 29 August 2017. https://www.clinicaltrials.gov/ct2/show/NCT03264625?term=NCT 03264625&rank=1, assessed on 1 July 2019.

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Administration of vitamin D to ameliorate dyspnea of chronic obstructive pulmonary disease patients: a randomized controlled trial

Immunopathologia Persa ◽

10.15171/ipp.2019.22 ◽

2019 ◽

Vol 5 (2) ◽

pp. e22-e22

Author(s):

Samad Ghodrati ◽

Arian Ezzatpanah ◽

Masoud Asadi-Khiavi ◽

Shohreh Alian Samakkah ◽

Abdolreza Esmaeilzadeh ◽

...

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Vitamin D ◽

Randomized Controlled Trial ◽

Pulmonary Disease ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Control Group ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Randomized Controlled

Introduction: As one of the most common causes of human morbidity and mortality, chronic obstructive pulmonary disease (COPD) affects millions around the world. Some evidences have already considered about association between serum levels of vitamin D and COPD. Objectives: This study was aimed to evaluate the effects of vitamin D supplementation on COPD improvement. Patients and Methods: This study was designed as a randomized controlled trial. Forty COPD patients with vitamin D deficiency were enrolled into two groups; cases group who administered vitamin D and control group who received placebo. The severity of dyspnea and spirometric indices were analyzed in both groups. Values were presented as mean and standard deviation (SD) and differences were considered significant at the level of P<0.05. Results: Spirometric indices did not show significant differences before and after vitamin D administration (P>0.05). Dyspnea severity was significantly improved after receiving vitamin D supplementation in comparison with placebo consumption (P=0.03). Conclusion: Spirometric indices were not affected during vitamin D supplementation therapy but it showed a significantly positive effect on the curing of dyspnea. Therefore, adjuvant therapy of COPD using vitamin D supplementation is recommended to better handling of dyspnea in COPD cases.

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Self-Directed Oral Vitamin D Supplementation in Professional Ballet Dancers: A Randomized Controlled Trial Pilot Study

Journal of Dance Medicine & Science ◽

10.12678/1089-313x.23.3.91 ◽

2019 ◽

Vol 23 (3) ◽

pp. 91-96

Author(s):

Fiachra E. Rowan ◽

Harry Benjamin-Laing ◽

Aedín Kennedy ◽

Akbar De Medici ◽

Ian Beasley ◽

...

Keyword(s):

Vitamin D ◽

Randomized Controlled Trial ◽

Pilot Study ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Oral Vitamin ◽

Ballet Dancers ◽

Randomized Controlled

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A Randomized Controlled Trial and Radiographic Evaluation of Adjunctive Periodontal Treatment with Calcium and Vitamin D Supplementation

International Journal of Experimental Dental Science ◽

10.5005/jp-journals-10029-1123 ◽

2016 ◽

Vol 5 (1) ◽

pp. 50-55

Author(s):

Arpapan Bundit ◽

Pusadee Yotnuengnit ◽

Sirinun Wisetsin ◽

Apichart Chittacharoen

Keyword(s):

Vitamin D ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Test Group ◽

Vitamin D Supplementation ◽

Periodontal Treatment ◽

Radiographic Evaluation ◽

Control Group ◽

Bony Defect ◽

Randomized Controlled

ABSTRACT Aim The objective of this study was to use clinical parameters, digital subtraction analysis, and computer intensity measurement to evaluate the effect of calcium and vitamin D supplementation in adult periodontitis patients with vertical bony defect after initial therapy. Materials and methods A total of 31 systemically healthy patients with moderate to severe chronic periodontitis and normal serum calcium level were included. The most obvious proximal vertical bony defect was selected in each patient as an area of interest (AOI). Subjects received initial periodontal therapy. They were randomized into two groups. The test group (n= 17) received calcium (600 mg twice daily) and vitamin D (0.25 µg once daily) supplements for 6 months. The control group (n= 14) received placebos. At baseline and 6 months, probing pocket depth (PPD), clinical attachment level (CAL), and standardized vertical bitewing radiographs were recorded for the AOI. Results A greater percentage of patients in the test group (64.7%) than in the control group (35.7%) gained bone according to both radiographic evaluation methods. At baseline and 6 months, no significant intragroup or intergroup differences in PPD and CAL were observed. Slightly greater PPD reduction and CAL gain were noted in the test group. Conclusion Periodontal healing of vertical bony defects was better among patients who used calcium and vitamin D supplements than among control patients. Although the difference was not statistically different between the groups, the test group tended toward more improvement. How to cite this article Bundit A, Yotnuengnit P, Wisetsin S, Chittacharoen A. A Randomized Controlled Trial and Radiographic Evaluation of Adjunctive Periodontal Treatment with Calcium and Vitamin D Supplementation. Int J Experiment Dent Sci 2016;5(1):50-55.

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