Primary prevention of fractures in the elderly: randomised controlled trial (RCT) of an annual injection of vitamin D in the prevention of hip and other non-vertebral fractures

AbstractInsufficient vitamin D status (serum 25-hydroxyvitamin D (S-25(OH)D)<50 nmol/l) is common among immigrants living at the northern latitudes. We investigated ethnic differences in response of S-25(OH)D to vitamin D3 supplementation, through a 5-month randomised controlled trial, in East African and Finnish women in Southern Finland (60°N) from December 2014 to May 2015. Vitamin D intakes (dietary and supplemental) were also examined. Altogether, 191 subjects were screened and 147 women (East Africans n 72, Finns n 75) aged 21–64 years were randomised to receive placebo or 10 or 20 µg of vitamin D3/d. S-25(OH)D concentrations were assessed by liquid chromatography–tandem MS. At screening, 56 % of East Africans and 9 % of Finns had S-25(OH)D<50 nmol/l. Total vitamin D intake was higher in East Africans than in Finns (24·2 (sd 14·3) v. 15·2 (sd 13·4) µg/d, P<0·001). Baseline mean S-25(OH)D concentrations were higher in Finns (60·5 (sd=16·3) nmol/l) than in East Africans (51·5 (sd 15·4) nmol/l) (P=0·001). In repeated-measures ANCOVA (adjusted for baseline S-25(OH)D), mean S-25(OH)D increased by 8·5 and 10·0 nmol/l with a 10-µg dose and by 10·7 and 17·1 nmol/l with a 20-µg dose for Finns and East Africans, respectively (P>0·05 for differences between ethnic groups). In conclusion, high prevalence of vitamin D insufficiency existed among East African women living in Finland, despite higher vitamin D intake than their Finnish peers. Moderate vitamin D3 supplementation was effective in increasing S-25(OH)D in both groups of women, and no ethnic differences existed in the response to supplementation.

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Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

Diabetologia ◽

10.1007/s00125-011-2357-4 ◽

2011 ◽

Vol 55 (1) ◽

pp. 36-45 ◽

Cited By ~ 32

Author(s):

Keyword(s):

Vitamin D ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Design History ◽

Randomised Controlled

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Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial

Gut ◽

10.1136/gutjnl-2020-321585 ◽

2020 ◽

pp. gutjnl-2020-321585 ◽

Cited By ~ 3

Author(s):

Suzanne E Mahady ◽

Karen L Margolis ◽

Andrew Chan ◽

Galina Polekhina ◽

Robyn L Woods ◽

...

Keyword(s):

Risk Factors ◽

Randomised Controlled Trial ◽

Absolute Risk ◽

Controlled Trial ◽

Bleeding Risk ◽

The Elderly ◽

Community Dwelling ◽

Gi Bleeding ◽

Prophylactic Use ◽

Randomised Controlled

ObjectiveThere is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.DesignData were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010–2017 (‘ASPirin in Reducing Events in the Elderly (ASPREE)’, n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.ResultsOver a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.ConclusionAspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.Trial registration numberASPREE. NCT01038583.

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Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants

Journal of Paediatrics and Child Health ◽

10.1111/jpc.13338 ◽

2016 ◽

Vol 53 (2) ◽

pp. 163-169 ◽

Cited By ~ 19

Author(s):

Julie Huynh ◽

Thao Lu ◽

Danny Liew ◽

James CG Doery ◽

Ronald Tudball ◽

...

Keyword(s):

Vitamin D ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Randomised Controlled

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P1927A European randomised controlled trial for m-health guided cardiac rehabilitation in the elderly; results of the EU-CaRE RCT study

European Heart Journal ◽

10.1093/eurheartj/ehz748.0674 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

E P De Kluiver ◽

A E Van Der Velde ◽

E P Meindersma ◽

L F Prins ◽

M Wilhelm ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cardiac Rehabilitation ◽

Controlled Trial ◽

The Elderly ◽

Lv Function ◽

Random Factor ◽

Index Event ◽

The Difference ◽

Randomised Controlled ◽

The Eu

Abstract Introduction Knowledge about effectiveness of cardiac rehabilitation (CR) in the elderly is limited. Participation rates in supervised CR are consistently lower in the elderly and innovative interventions are needed. The EU has granted a CR study project; a randomised controlled trial conducted in 5 European countries, investigating the effectiveness of mobile telemonitoring guided CR (mCR) in elderly cardiac patients who declined regular CR. Methods Patients ≥65 years with indication for CR who declined regular CR were eligible for inclusion. Patients were randomised between regular care (without CR) and a 6-month mCR programme: dedicated programmed smartphone, heartrate monitoring (target HR zones) and coaching. The primary endpoint is the difference in VO2peak between 6-months follow-up and baseline. Results Between 2015 and 2018 179 patients were included. Baseline characteristics between groups (table 1) did not differ significantly, except for hypertension. The difference in VO2peak was significantly better in the mCR group (table 1). After correction (mixed linear model) for baseline VO2 peak (fixed factor) and centre (random factor) this difference remained significant. Mean number of registered activity sessions was 4.79 (95% CI; 4.07–5.50) per patient per week. Table 1. Baseline and primary outcome parameters Baseline Control Programme (n=90) mCR Programme (n=89) P-value Gender (m/f) 76/14 69/20 0.238 Age (mean±SD) 73.57±5.46 72.38±5.37 0.121 Diabetes 15 (16.7%) 23 (25.8%) 0.133 Hypertension 60 (66.7%) 73 (82.0%) 0.019* Hypercholesteremia 71 (78.3%) 74 (83.1%) 0.468 Normal LV-function 48/89 (53.9%) 53/89 (59.6%) 0.497 Index event (CABG/Valve/PCI/none) 0.735 Cardiac history prior to index event 48/89 (53.9%) 53/89 (59.6%) 0.702 Non cardiac comorbidity 40 (44.4%) 44 (49.4%) 0.503 Results Baseline VO2peak (ml/kg/min) (95% CI) 19.83 (18.65–21.01) 18.78 (18.67–19.89) 0.191 Delta VO2peak at 6 months (ml/kg/min) (95% CI) 0.20 4 (−0.34–0.83) 1.62 (0.86–2.39) 0.005* Corrected delta VO2peak at 6 months (ml/kg/min) 0.50 (−1.04–2.04) 1.65 (0.11–3.2) 0.015* *Significant. Conclusions The application of mCR in elderly patients who declined regular CR results in a better physical condition after 6 months. Compliance to mCR was excellent. Acknowledgement/Funding European Union's Horizon 2020 research and innovation programme under grant agreement number 634439, and funding from the Swiss Government.

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