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Background Among individuals with vitamin D deficiency, daily vitamin D supplementation appears to lower risk of acute respiratory infection. However, recent trials, in different populations and using different regimens, have yielded null results. We investigated the effect of daily vitamin D supplementation (vs placebo) on risk of upper respiratory infection (URI) in older adults. Methods The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial of supplemental vitamin D and/or omega-3 fatty acids in generally healthy men (age ≥50 years) and women (age ≥55 years). This prespecified analysis focuses on vitamin D3 (2000 IU/day) versus placebo in the 15 804 (61%) participants with baseline serum total 25-hydroxyvitamin D level. The primary outcome was self-report of a recent URI at 1-year follow-up. Results Participants had a mean age of 68 years and 51% were women; 76% were non-Hispanic White, 16% Black, and 8% other race/ethnicity. The mean 25-hydroxyvitamin D level at baseline was 31 (standard deviation, 10) ng/mL, with <12 ng/mL in 2.4%. The overall effect of vitamin D supplementation on recent URI was nonsignificant (odds ratio [OR], 0.96 [95% confidence interval {CI},.86–1.06]). In the prespecified subgroup of primary interest (<12 ng/mL and denied taking concurrent vitamin D), which had only 255 participants, vitamin D supplementation was nonsignificant (OR, 0.60 [95% CI,.28–1.30]). Statistical power to assess effect modification in other subgroups was limited. Conclusions In older adults not selected for vitamin D deficiency, supplemental vitamin D did not lower URI risk overall. Whether effects differ in subgroups requires further study. Clinical Trials Registration. NCT01169259. [ABSTRACT FROM AUTHOR]

Objectives To assess eligibility criteria that either explicitly or implicitly exclude older patients from randomized controlled trials (RCTs) in RA. Methods Our analysis included RCTs of pharmacological interventions registered with ClinicalTrials.gov and started between 2013 and 2022. Co-primary outcomes were proportions of trials with an upper age limit and the eligibility criteria indirectly increasing risk of the exclusion of older adults. Results A total of 143/290 (49%) trials had an upper age limit of 85 years or less. Multivariable analysis showed that the odds of an upper age limit were significantly lower in trials performed in the USA [adjusted odds ratio (aOR), 0.34; CI, 0.12–0.99; P  = 0.04] and intercontinental trials (aOR, 0.4; CI, 0.18–0.87; P  = 0.02). In total, 154/290 (53%) trials had at least one eligibility criterion implicitly excluding older adults. These included specific comorbidities (n  = 114; 39%), compliance concerns (n  = 67; 23%), and broad and vague exclusion criteria (n  = 57; 20%); however, we found no significant associations between these criteria and trial characteristics. Overall, 217 (75%) trials either explicitly or implicitly excluded older patients; we also noted a trend towards increasing proportion of these trials over time. Only one trial (0.3%) enrolled solely patients aged 65 and older. Conclusion Older adults are commonly excluded from RCTs in RA based on both age limits and other eligibility criteria. This seriously limits the evidence base for the treatment of older patients in clinical practice. Given the growing prevalence of RA in older adults, relevant RCTs should be more inclusive to them. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to examine the effects of visual art therapy (VAT) on cognition, psychological and functional ability of people with mild cognitive impairment (MCI), and low education. Methods A single-blinded randomized controlled trial was conducted among 127 older adults with MCI, mean age 73.6 years, and level of education in years, median (range) = 0 (0–9). The intervention group received 12 VAT sessions over 6 weeks. The control group received 6 health education sessions. The outcomes measures at baseline, immediately postintervention, at 3-month, and 6-month follow-up included global cognitive functions, depression, mental well-being, and instrumental activities of daily living functions. Results The intervention group demonstrated greater improvement than the control group in global cognition (β = 2.56, 95% confidence interval [CI] = 1.16, 3.97, p <.001, standardized mean difference [SMD] = 0.75) and depression (β = −2.01, 95% CI = −3.09, −0.93, p <.001, SMD = −0.93) immediately postintervention. The effects on cognitive functions were sustained at 3 and 6 months follow-up. The differential effect of VAT on mental well-being and functional ability compared to health education were undetectable. Discussion VAT can improve cognitive functions and mood status of older adults with MCI who have no or low education. Clinical Trials Registration Number: PACTR201901731800445. This trial was registered with Pan African Clinical Trial Registry: www.pactr.org. [ABSTRACT FROM AUTHOR]

Background Hydration therapy is essential in the care of the older patient. Subcutaneous (SC) hydration is a relevant method for parenteral hydration, but clinical trials on the subject have methodological shortcomings compared to updated standards. Design Assessor-blinded, non-inferiority RCT to explore if SC is a safe alternative to intravenous (IV) hydration. Participants Eligible patients were: Admitted patients 65 years or older with a need for parenteral hydration. The targeted sample size was 67 patients in each group. Intervention Patients were randomised to parenteral hydration via an IV or SC catheter during a 24 hours observation period. The non-randomised catheter (inactive) was placed as a sham on the patient, thereby blinding the caregivers and outcome assessors. Measurement Our primary outcome was the proportion of patients reporting at least one adverse effect with a non-inferiority calculation using a 20% margin. Results We included 51 patients, with 24 randomised to SC and 27 to IV. We were unable to reach our target sample size due to challenges in recruitment, time limitation, and COVID-19. For the outcome of adverse effects, SC was non-inferior to IV (p = 0.012). Time spent on inserting the catheters was shorter with SC (p = 0.001). The groups did not differ by pain of insertion, discomfort during infusion, or the risk of developing delirium. Conclusion SC is a safe alternative to IV hydration, is faster to place and should be an available method for parenteral hydration wherever older adults are cared for. Trial registration ClinicalTrials.gov Identifier: NCT03710408 [ABSTRACT FROM AUTHOR]