Effect of dietary sources of calcium and protein on hip fractures and falls in older adults in residential care: cluster randomised controlled trialBMJ, The - Tập 375 - Trang - 2021
S Iuliano, S Poon, J Robbins, M Bui, X Wang, L De Groot, M Van Loan, A Ghasem Zadeh, T Nguyen, E Seeman
Objective To assess the antifracture efficacy and safety of a nutritional intervention in institutionalised older adults replete in vitamin D but with mean intakes of 600 mg/day calcium and <1 g/kg body weight protein/day.
Design Two year cluster randomised controlled trial.
Setting 60 accredited residential aged care facilities in Australia housing predominantly ambulant residents.
Participants 7195 permanent residents (4920 (68%) female; mean age 86.0 (SD 8.2) years).
Intervention Facilities were stratified by location and organisation, with 30 facilities randomised to provide residents with additional milk, yoghurt, and cheese that contained 562 (166) mg/day calcium and 12 (6) g/day protein achieving a total intake of 1142 (353) mg calcium/day and 69 (15) g/day protein (1.1 g/kg body weight). The 30 control facilities maintained their usual menus, with residents consuming 700 (247) mg/day calcium and 58 (14) g/day protein (0.9 g/kg body weight).
Main outcome measures Group differences in incidence of fractures, falls, and all cause mortality.
Results Data from 27 intervention facilities and 29 control facilities were analysed. A total of 324 fractures (135 hip fractures), 4302 falls, and 1974 deaths were observed. The intervention was associated with risk reductions of 33% for all fractures (121 v 203; hazard ratio 0.67, 95% confidence interval 0.48 to 0.93; P=0.02), 46% for hip fractures (42 v 93; 0.54, 0.35 to 0.83; P=0.005), and 11% for falls (1879 v 2423; 0.89, 0.78 to 0.98; P=0.04). The risk reduction for hip fractures and falls achieved significance at five months (P=0.02) and three months (P=0.004), respectively. Mortality was unchanged (900 v 1074; hazard ratio 1.01, 0.43 to 3.08).
Conclusions Improving calcium and protein intakes by using dairy foods is a readily accessible intervention that reduces the risk of falls and fractures commonly occurring in aged care residents.
Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000228785.
The dataset is available from the corresponding author.
Angiotensin receptor blockers for the treatment of covid-19: pragmatic, adaptive, multicentre, phase 3, randomised controlled trialBMJ, The - - Trang e072175
Meg Jardine, Sradha Kotwal, Abhinav Bassi, Carinna Hockham, Mark Jones, Arlen Wilcox, Carol A. Pollock, Louise M. Burrell, James M. McGree, Vinay Rathore, Christine Jenkins, Lalit Gupta, Angus Ritchie, Ashpak Bangi, Sanjay D′Cruz, Andrew J. McLachlan, Simon Finfer, Michelle M. Cummins, Tom Snelling, Vivekanand Jha
Abstract
Objective
To determine whether disrupting the renin angiotensin system with angiotensin receptor blockers will improve clinical outcomes in people with covid-19.
Design
CLARITY was a pragmatic, adaptive, multicentre, phase 3, randomised controlled trial.
Setting
17 hospital sites in India and Australia.
Participants
Participants were at least 18 years old, previously untreated with angiotensin receptor blockers, with a laboratory confirmed diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection who had been admitted to hospital for management of covid-19.
Intervention
Oral angiotensin receptor blockers (telmisartan in India) or placebo (1:1) for 28 days.
Main outcome measures
The primary endpoint was covid-19 disease severity using a modified World Health Organization Clinical Progression Scale (WHO scale) at day 14. Secondary outcomes were WHO scale scores at day 28, mortality, intensive care unit admission, and respiratory failure. Analyses were evaluated on an ordinal scale in the intention-to-treat population.
Results
Between 3 May 2020 and 13 November 2021, 2930 people were screened for eligibility, with 393 randomly assigned to angiotensin receptor blockers (of which 388 (98.7%) to telmisartan 40 mg/day) and 394 to the control group. 787 participants were randomised: 778 (98.9%) from India and nine (1.1%) from Australia. The median WHO scale score at day 14 was 1 (interquartile range 1-1) in 384 participants assigned angiotensin receptor blockers and 1 (1-1) in 382 participants assigned placebo (adjusted odds ratio 1.51 (95% credible interval 1.02 to 2.23), probability of an odds ratio of >1 (Pr(OR>1)=0.98). WHO scale scores at day 28 showed little evidence of difference between groups (1.02 (0.55 to 1.87), Pr(OR>1)=0.53). The trial was stopped when a prespecified futility rule was met.
Conclusions
In patients admitted to hospital for covid-19, mostly with mild disease, not requiring oxygen, no evidence of benefit, based on disease severity score, was found for treatment with angiotensin receptor blockers, using predominantly 40 mg/day of telmisartan.
Trial registration
ClinicalTrials.gov
NCT04394117
.
PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviewsBMJ, The - - Trang n160
Matthew J. Page, David Moher, Patrick M. Bossuyt, Isabelle Boutron, Tammy Hoffmann, Cynthia D. Mulrow, Larissa Shamseer, Jennifer Tetzlaff, Elie A. Akl, Sue Brennan, Roger Chou, Julie Glanville, Jeremy Grimshaw, Asbjørn Hróbjartsson, Manoj M. Lalu, Tianjing Li, Elizabeth Loder, Evan Mayo‐Wilson, Steve McDonald, Luke A. McGuinness, Lesley Stewart, James Thomas, Andrea C. Tricco, Vivian Welch, Penny Whiting, Joanne E. McKenzie
