Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis

Introduction Clinical trials and systematic reviews of trials involving vitamin D supplementation have mainly focused on defining the optimal amount of vitamin D dosage. However, the comparative effectiveness of different dosing schedules (ie, daily vs bolus dosing schedule) has been largely unexplo...

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Main Authors: Jemila Hamid, Banaz Al-khalidi, Joycelyne Efua Ewusie, Samantha Kimball
Format: Article
Language:English
Published: BMJ Publishing Group 2019-08-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/8/e027349.full
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author Jemila Hamid
Banaz Al-khalidi
Joycelyne Efua Ewusie
Samantha Kimball
author_facet Jemila Hamid
Banaz Al-khalidi
Joycelyne Efua Ewusie
Samantha Kimball
author_sort Jemila Hamid
collection DOAJ
description Introduction Clinical trials and systematic reviews of trials involving vitamin D supplementation have mainly focused on defining the optimal amount of vitamin D dosage. However, the comparative effectiveness of different dosing schedules (ie, daily vs bolus dosing schedule) has been largely unexplored; and currently, there is no consensus regarding the optimal vitamin D dosing schedule. Our objective is to conduct a systematic review and network meta-analysis (NMA) to evaluate the comparative effectiveness and safety of steady (eg, daily, weekly) and intermittent high-dose (eg, monthly, yearly) vitamin D dosing schedules; and to determine the effectiveness of the various dosing schedules and combinations of treatments.Methods and analysis We will conduct a systematic search and review of literature from major medical databases (MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) involving studies that compare vitamin D supplementation alone or in combination with calcium. Only randomised controlled trials (RCTs) will be considered. We will, however, consider various settings (eg, community, institutional care) and study designs (eg, cluster RCTs, cross-over trials). Our primary outcomes include falls and fractures including hip-fracture and non-vertebral fractures. Secondary outcomes will include muscle strength, physical performance, gait and mobility limitation. A Bayesian NMA will be conducted, and the results will be presented in the form of treatment effect estimates and ranking probabilities, with corresponding CIs. Pairwise meta-analysis will also be conducted for studies reporting head-to-head comparisons. Subgroup analysis will be performed with respect to pre-determined subgroups; including vitamin D status as measured by serum 25-hydroxyvitamin D levels, age and follow-up time. Sensitivity analysis will also be performed with respect to risk of bias.Ethics and dissemination This study is a systematic review and meta-analysis of published RCTs; therefore, no ethical approval is required. Results will be disseminated through open access peer-reviewed publications.Systematic review registration PROSPERO CRD42018112662.
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spelling doaj-art-ffaf2c0a2ab3458d88feb1eb2f7470d62025-08-20T02:18:43ZengBMJ Publishing GroupBMJ Open2044-60552019-08-019810.1136/bmjopen-2018-027349Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysisJemila Hamid0Banaz Al-khalidi1Joycelyne Efua Ewusie2Samantha Kimball31 Children`s Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada1 School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada4 Research Department, Pure North S`Energy Foundation, Calgary, Alberta, CanadaIntroduction Clinical trials and systematic reviews of trials involving vitamin D supplementation have mainly focused on defining the optimal amount of vitamin D dosage. However, the comparative effectiveness of different dosing schedules (ie, daily vs bolus dosing schedule) has been largely unexplored; and currently, there is no consensus regarding the optimal vitamin D dosing schedule. Our objective is to conduct a systematic review and network meta-analysis (NMA) to evaluate the comparative effectiveness and safety of steady (eg, daily, weekly) and intermittent high-dose (eg, monthly, yearly) vitamin D dosing schedules; and to determine the effectiveness of the various dosing schedules and combinations of treatments.Methods and analysis We will conduct a systematic search and review of literature from major medical databases (MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) involving studies that compare vitamin D supplementation alone or in combination with calcium. Only randomised controlled trials (RCTs) will be considered. We will, however, consider various settings (eg, community, institutional care) and study designs (eg, cluster RCTs, cross-over trials). Our primary outcomes include falls and fractures including hip-fracture and non-vertebral fractures. Secondary outcomes will include muscle strength, physical performance, gait and mobility limitation. A Bayesian NMA will be conducted, and the results will be presented in the form of treatment effect estimates and ranking probabilities, with corresponding CIs. Pairwise meta-analysis will also be conducted for studies reporting head-to-head comparisons. Subgroup analysis will be performed with respect to pre-determined subgroups; including vitamin D status as measured by serum 25-hydroxyvitamin D levels, age and follow-up time. Sensitivity analysis will also be performed with respect to risk of bias.Ethics and dissemination This study is a systematic review and meta-analysis of published RCTs; therefore, no ethical approval is required. Results will be disseminated through open access peer-reviewed publications.Systematic review registration PROSPERO CRD42018112662.https://bmjopen.bmj.com/content/9/8/e027349.full
spellingShingle Jemila Hamid
Banaz Al-khalidi
Joycelyne Efua Ewusie
Samantha Kimball
Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis
BMJ Open
title Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis
title_full Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis
title_fullStr Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis
title_full_unstemmed Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis
title_short Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis
title_sort effectiveness and safety of steady versus intermittent high dose vitamin d supplementation for the prevention of falls and fractures among adults a protocol for systematic review and network meta analysis
url https://bmjopen.bmj.com/content/9/8/e027349.full
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