Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment

BackgroundThe VITamin D and OmegA-3 TriaL (VITAL) is a completed randomized, placebo-controlled trial of vitamin D₃ (2000 IU/day) and marine omega-3 (1 g/day) supplements in the primary prevention of cancer and cardiovascular disease. Here we examine baseline and change in 25-hydroxyvitamin D (25(OH)D) and related biomarkers with randomized treatment and by clinical factors.MethodsBaseline 25(OH)D was measured in 15,804 participants (mean age 68 years.; 50.8% women; 15.7% African Americans) and in 1660 1-year follow-up samples using liquid chromatography-tandem mass spectrometry and chemiluminescence. Calcium and parathyroid hormone (iPTH) were measured by chemiluminescence and spectrophotometry respectively.ResultsMean baseline total 25(OH)D (ng/mL ± SD) was 30.8 ± 10.0 ng/mL, and correlated inversely with iPTH (r = −0.28), p < .001. After adjusting for clinical factors, 25(OH)D (ng/mL ± SE) was lower in men vs women (29.7 ± 0.30 vs 31.4 ± 0.30, p < .0001) and in African Americans vs whites (27.9 ± 0.29 vs 32.5 ± 0.22, p < .0001). It was also lower with increasing BMI, smoking, and latitude, and varied by season. Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo. The largest increases were noted among individuals with low baseline and African Americans. Results were similar for chemiluminescent immunoassay. Mean calcium was unchanged, and iPTH decreased with treatment.ConclusionIn VITAL, baseline 25(OH)D varied by clinical subgroups, was lower in men and African Americans. Concentrations increased with vitamin D supplementation, with the greatest increases in those with lower baseline 25(OH)D. The seasonal trends in 25(OH)D, iPTH, and calcium may be relevant when interpreting 25(OH)D levels for clinical treatment decisions.Clinical Trial Registration: VITAL ClinicalTrials.gov number NCT01169259.     

The influence of maternal vitamin D supplementation on infant vitamin D status: A systematic review and meta-analyses

BackgroundInconsistencies exist with regard to effect of maternal vitamin D supplementation on infant vitamin D status. The inconsistencies could be attributed to numerous factors, such as duration of intervention and dosage, among others. In this work, we conducted a systematic review and meta-analysis to determine the influence of maternal vitamin D supplementation on infant vitamin D status.MethodsA comprehensive systematic search was performed in Scopus, EMBASE, Web of Science, and PubMed/MEDLINE, by investigators, from database inception until November 2019, without using any restrictions. Weighted mean difference (WMD) with the 95 % CI was used for assessing the effects of maternal vitamin D supplementation on 25(OH) D levels in infants.ResultsOverall results from 14 studies revealed a non-significant effect of maternal vitamin D administration on the level of 25(OH) D in breastfeeding infants (WMD: -0.464 ng/mL, 95 % CI: -6.68 to 5.75, p = 0.884, I² = 98 %). Subgroup analyses demonstrated that vitamin D supplementation dosage ≥2000 IU/day (WMD: 9 ng/mL, 95 % CI: 8.19, 9.82, I² = 99 %) and intervention duration ≥20 weeks (WMD: 16.20 ng/mL, 95 % CI: 14.89, 17.50, I² = 99 %) significantly increased 25(OH) D.ConclusionsThe main results indicate a non-significant increase in infant vitamin D following maternal vitamin D supplementation. Additionally, vitamin D supplementation dosage ≥2000 IU/day and intervention duration ≥20 weeks significantly increased infant 25(OH) D.     

The effects of an enteral nutrition feeding protocol on critically ill patients: A prospective multi-center,before-after study

PurposeThe aim of this study was to explore the effects of an enteral nutrition (EN) feeding protocol in critically ill patients.MethodsThis was a prospective multi-center before-after study. We compared energy related and prognostic indicators between the control group (pre-implementation stage) and intervention group (post-implementation stage). The primary endpoint was the percentage of patients receiving EN within 7 days after ICU admission.Results209 patients in the control group and 230 patients in the intervention group were enrolled. The implementation of the EN protocol increased the percentage of target energy reached from day 3 to day 7, and the difference between two groups reached statistical significance in day 6 (P = .01) and day 7 (P = .002). But it had no effects on proportion of patient receiving EN (P = .65) and start time of EN (P = .90). The protocol application might be associated with better hospital survival (89.1% vs 82.8%, P = .055) and reduce the incidence of EN related adverse (P = .004). There was no difference in ICU length of stay, duration of mechanical ventilation and ICU cost.ConclusionThe implementation of the enteral feeding protocol is associated with improved energy intake and a decreased incidence of enteral nutrition related adverse events for critically ill patients, but it had no statistically beneficial effects on reducing the hospital mortality rate.Trial registrationClinicalTrials.gov, NCT02976155. Registered November 29, 2016- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02976155.     

补充维生素D对冠心病患者冠状动脉病变程度的影响

目的:探讨维生素D干预对冠心病患者冠状动脉Gensini评分的影响及其相关性。方法:采用前瞻性研究方法,选择109例行冠脉CT的冠心病患者为研究对象。将患者分为对照组和干预组,均给予冠心病二级预防药物治疗,干预组加用维D钙片口服及维生素D2肌肉注射治疗。观察两组患者治疗前后各临床指标及冠状动脉Gensini评分的变化,分析各临床指标、维生素D与冠状动脉Gensini评分的相关性。结果:干预组患者治疗后三酰甘油(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、血磷、红细胞沉降率(ESR)、超敏C反应蛋白(hs-CRP)水平和冠状动脉Gensini评分均低于治疗前(P<0.05),高密度脂蛋白胆固醇(HDL-C)、血钙、25羟维生素D[25(OH)D]均高于治疗前(P<0.05)。干预组治疗前后TC、LDL-C、钙、25(OH)D、ESR、hs-CRP及冠状动脉Gensini评分的差值大于对照组(P<0.05)。Pearson相关分析显示,补充维生素D与否、年龄、LDL-C、HDL-C、TC、空腹血糖(FPG)、糖化血红蛋白(HbA1c)、hs-CRP、维生素D水平与冠状动脉Gensini评分明显相关,相关系数分别为-0.519、0.357、0.725、-0.632、0.419、0.290、0.327、0.599、-0.478;多因素线性回归分析显示,LDL-C、hs-CRP升高是冠状动脉病变的危险因素(Gensini评分增加),补充维生素D及HDL-C、维生素D水平升高是冠状动脉病变的保护性因素(Gensini评分减小)。结论:血清维生素D水平与冠状动脉严重程度负相关,提高25(OH)D水平可降低冠心病患者冠状动脉病变严重程度。     

Common genetic variants of the vitamin D binding protein (DBP) predict differences in response of serum 25-hydroxyvitamin D [25(OH)D] to vitamin D supplementation

BackgroundTo determine the effect of vitamin D binding protein (DBP) genotypes on 25-hydroxyvitamin D [25(OH)D] changes with vitamin D supplements, we studied 98 adults receiving 600 or 4000 IU/d vitamin D₃ for one year.MethodsThe DBP functional variant, T436K, was genotyped by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).ResultsMean 25(OH)D increases were 97% for TT (n = 48), 151% for TK (n = 31) and 307% (n = 6) for KK genotypes (p = .004).ConclusionsAs with baseline 25(OH)D, T436K genotype predicts 25(OH)D changes after long-term vitamin D supplementation.     

Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes

BackgroundAdolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.MethodsThis research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).DiscussionAYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.Trial registrationThe study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).     

Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART)

BackgroundThere is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).MethodsIn this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.ResultsAt least 296 participants and approximately 75 peer supporters will be enrolled.DiscussionDespite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.Trial Registration: The ClinicalTrials.gov registration number is NCT03689530.     

Time limited eating in adolescents with obesity (time LEAd): Study protocol

BackgroundTime limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.ObjectivesThe aim of this study is to assess the feasibility of a TLE approach in adolescents with obesity using a continuous glucose monitor (CGM) to promote adherence to the intervention.MethodsWe propose a prospective, randomized controlled trial, in 60 adolescents (ages 14–18) with obesity (BMI% ≥ 95th percentile). Youth will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy). Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline.ConclusionsTLE is a potentially powerful lifestyle intervention that could be readily integrated into pediatric weight management programs to optimize their impact and accelerate healthy changes.Clinical trial registrationClinicalTrials.gov identifier: NCT03954223     

Ethnic,geographic, and seasonal differences of vitamin D status among adults in south-west China

BackgroundThere are limited data on vitamin D status of Sichuan province, and no investigation has been carried out on the correlations of 25(OH)D and BTMs between healthy Hans and Tibetans of Sichuan province. This study aimed to examine 25(OH)D levels around Sichuan province and to assess differences by ethnicity, age, gender, sunlight exposure, geographic location, and seasons.MethodsBlood samples from 2317 healthy adults aged of 18 to 75 years and of Han and Tibetan ethnicities were collected in six regions and during four seasons. Serum 25(OH)D₂ and 25(OH)D₃ levels were measured by LC‐MS/MS method. Serum total P1NP and β‐CTX were measured by immunoassay.ResultsParticipants aged 18‐40 years showed significantly lower 25(OH)D levels than participants aged 41‐75 years old (P < .0001). The median serum 25(OH)D level for males was significantly higher than that of females (P < .0001). Serum 25(OH)D levels among four seasons and different districts varied significantly (P < .0001). In addition, the 25(OH)D level of Tibetans was significantly lower than that of Hans, while the serum total P1NP and β‐CTX levels of Tibetans were significantly higher than those of Hans (P < .0001).ConclusionAdult population was more common to have vitamin D deficiency/insufficiency among Tibetans, females, north regions and in spring and winter.     

Comparative analysis of the association between various serum vitamin D biomarkers and sarcopenia

BackgroundVitamin D status is associated with muscle strength and maintenance of muscle fibers. However, which serum vitamin D biomarker better reflects sarcopenia remains unclear. The aim of this study was to investigate associations between various serum vitamin D biomarkers (total 25‐hydroxy vitamin D [25(OH)D], bioavailable 25(OH)D, 24,25‐dihydroxyvitamin D [24,25(OH)₂D], and vitamin D metabolite ratio [VMR]) and sarcopenia.MethodsThe data for 83 hip fracture patients were finally included in the analysis. Sarcopenia was defined according to the Asia Working Group for Sarcopenia (AWGS) criteria. Measurements of 24,25(OH)₂D and 25(OH)D were made using solid‐phase extraction (SPE) and subsequent liquid chromatography‐tandem mass spectrometry (LC‐MS/MS). Vitamin D binding protein (VDBP) concentration was measured using an enzyme‐linked immunosorbent assay. The VMR was calculated by dividing serum 24,25(OH)₂D by serum 25(OH)D and then multiplying by 100. Based on total 25(OH)D, VDBP, and albumin concentrations, bioavailable 25(OH)D concentrations were calculated using the equations from the other previous studies.ResultsBioavailable 25(OH)D levels were significantly (p = 0.030) decreased in the sarcopenia group compared with the non‐sarcopenia group. Results of ROC analysis for the diagnosis of sarcopenia using serum level of bioavailable of 25(OH)D revealed that the cutoff point for bioavailable 25(OH)D was 1.70 ng/ml (AUC = 0.649, p < 0.001). In the group with a bioavailable 25(OH)D less than 1.70 ng/ml, the incidence of sarcopenia increased by 3.3 times (odds ratio: 3.33, p = 0.013).ConclusionWe demonstrated that bioavailable 25(OH)D was associated with sarcopenia among the various serum vitamin D biomarkers. Bioavailable vitamin D might be helpful for assessing the risk of sarcopenia.     

Measured free 25-hydroxyvitamin D in healthy children and relationship to total 25-hydroxyvitamin D,calculated free 25-hydroxyvitamin D and vitamin D binding protein

Backgroundvitamin D deficiency in children is still a global health problem. Measuring free 25-hydroxyvitamin D concentrations could provide a better estimate of the vitamin D status than total 25-hydroxyvitamin D (25(OH)D) levels.ObjectiveTo assess the relationship between measured free vitamin D (m-f25(OH)D) and calculated free 25(OH)D (c-f25(OH)D), total 25(OH)D, intact parathyroid hormone (iPTH) and other markers of phosphocalcic metabolism.To establish serum m-f25(OH)D concentrations corresponding to a total 25(OH)D > 50 nmol/L which is accepted as vitamin D-sufficiency status in children.DesignProspective cohort study.SettingJanuary and February 2017 in a Mediterranean population.Patientshealthy children.Measurementsm-f25(OH)D and vitamin D binding protein (VDBP) by ELISA. Free 25(OH)D was calculated using the formula described by Bikle.Resultsm-f25(OH)D directly correlated with total 25(OH)D (r:0.804,p < .001), serum calcium (r:0.26,p:0.035), and c-f25(OH)D (r:0.553,p:0.016); and inversely with iPTH (r:-0.374, p:0.002), alkaline phosphatase (r:-0.28, p:0.026), and age (r:-0.289, p:0.018). Total 25(OH)D correlated with the same parameters as m-f25(OH)D except for serum calcium. However, c-f25(OH)D correlated only with total 25(OH)D and VDBP, both included in the calculation formula.Multiple regression analysis showed that m-f25(OH)D variations were independently explained by calcium (β:0.156, p:0.026) and total 25(OH)D (β:0.043, p < .001).The optimal m-f25(OH)D cut-off for discriminating between insufficient and sufficient total 25(OH)D was >9.8 pmol/L (Area Under Curve (AUC): 0.897 (95% confidence interval (CI): (0.798–0.958); p < .001; sensitivity:72.7% (95%CI: 49.8–89.3); specificity: 95.5% (95%CI: 84.5–99.4)).ConclusionsDirectly measured free vitamin D correlated better with markers of phosphocalcic metabolism than total 25(OH)D and c-f25(OH)D in a population of healthy children.     

2型糖尿病新发患者血清25羟维生素D_3的水平及临床意义

目的探讨2型糖尿病(T2DM)新发患者血清25羟维生素D_3[25-(OH)D_3]的水平,以及25-(OH)D_3与B细胞功能、胰岛素抵抗的关系。方法选取2013年1月至2016年6月于南京市中医院住院的T2DM新发患者48例为观察组,同时选取同期年龄匹配的健康体检者40例为对照组,留取血清及血浆标本测定空腹血糖(FBG)、空腹胰岛素(FIns)、血脂、糖化血红蛋白(HbA1c)以及血清25-(OH)D_3水平。比较两组间胰岛素抵抗指数(HOMA-IR)、胰岛B细胞功能指数(HOMA-β)及25-(OH)D_3等指标的差异,并分析25-(OH)D_3与HOMA-IR、HOMA-β的相关性。结果观察组FBG、血脂、HbA1c、HOMA-IR均高于对照组,且差异具有统计学意义(P0.05),而血清25-(OH)D_3水平、HOMA-β均低于对照组,且差异具有统计学意义(P0.05)。新发T2DM组患者血清25-(OH)D_3水平与FBG、HbA1c、HOMA-IR呈负相关(r值分别为-0.30,-0.34,-0.23,P0.05),与HOMA-β呈正相关(r=0.27,P0.05)。结论新发T2DM患者较对照组存在25-(OH)D_3水平低下,且血清25-(OH)D_3水平的降低与胰岛素抵抗和胰岛B细胞分泌功能下降有关。补充维生素D可能使患者获益。     

The relationship between renal injury and change in vitamin D metabolism in aged rats with insulin resistance or type 2 diabetes mellitus

Insulin resistance (IR), IR treated with vitamin D, IR treated with 1alpha-hydroxyvitamin D (1alpha-(OH)D), type 2 diabetes mellitus (T2DM), T2DM treated with vitamin D and T2DM treated with 1alpha-(OH)D were studied in animal models using aged Wistar rats. Glucose infusion rates and levels of urinary albumin (UA), serum 25-hydroxyvitamin D (25-(OH)D) and 1,25-dihydroxyvitamin D (1,25(OH)2D) were measured. T2DM rats had higher UA than IR or normal rats, and levels of 25-(OH)D in all models weresimilar. IR rats had higher 1,25-(OH)2D levels than T2DM rats, and had lower 1,25-(OH)2D levels than normal rats. Treating IR or T2DM rats with vitamin D had no effect on 25-(OH)D or 1,25-(OH)2D. Administration of 1alpha-(OH)D significantly increased 1,25-(OH)2D in IR rats to above-normal levels, and significantly increased 1,25-(OH)2D in T2DM rats to normal levels. In IR or T2DM, abnormal vitamin D metabolism is characterized by 1,25-(OH)2D deficiency and is related to renal injury.     

The effect of fenugreek seed supplementation on serum irisin levels,blood pressure,and liver and kidney function in patients with type 2 diabetes mellitus: A parallel randomized clinical trial

ObjectivesThis study was designed to determine the effects of fenugreek seed (FS) on serum irisin levels, blood pressure, and liver and kidney function in patients with type 2 diabetes mellitus (T2DM).MethodsIn an 8-week randomized controlled clinical trial, T2DM patients (n = 50) were assigned to the intervention (5 g FS powder, 3 times a day) or control group. Both groups received anti-diabetic drugs and nutritional consults. Serum samples were collected and blood pressure was measured at baseline and end of the trial. Data on dietary intake and physical activity was determined using the questionnaires.ResultsCompared to the control group, FS consumption resulted in a significant decrease in fasting plasma glucose (FPG) (p = 0.024), as well as a significant change in serum alanine aminotransferase (ALT) (p = 0.02) and alkaline phosphatase (ALP) (p = 0.001). Within-group analysis showed a significant decrease in aspartate aminotransferase (AST) (p = 0.014), systolic blood pressure (SBP) (p = 0.001), and irisin (p = 0.001) in the FS group, and a significant increase in creatinine (Cr) (p = 0.001) and decrease in estimated glomerular filtration rate (eGFR) (p = 0.001) in the control group. FS consumption did not have any significant effect on diastolic blood pressure (DBP) and blood urea nitrogen (BUN).ConclusionFS intake has some beneficial effects on FPG, SBP, and some liver and kidney function tests in patients with T2DM. Further studies are required to investigate the effect of FS on irisin levels. Trial registration number http://www.irct.ir, code: IRCT20190618043924N1     

Lavender essential oil on postmenopausal women with insomnia: Double-blind randomized trial

BackgroundTo evaluate the effect of Lavandula angustifolia essential oil inhalation on sleep and menopausal symptoms in postmenopausal women with insomnia.Participants35 postmenopausal women with a clinical diagnosis of insomnia were included, 17 in Aroma Group (AG) and 18 in Placebo Group (PG).MethodsIn this double-blind, randomized controlled trial, PG participants inhaled sunflower oil and AG participants inhaledLavandula angustifolia essential oil, for 29 days. Both groups received sleep hygiene guidelines before the intervention and weekly follow-up during it. Evaluations were performed before and after intervention. All statistical analyses and intention-to-treat test were performed in SPSS 22. Sleep quality (Primary outcome) was measured by Pittsburgh Sleep Quality Index. Secondary outcomes were polysomnography data, severity of insomnia, anxiety and depression symptoms, and postmenopausal symptoms.ResultsThere were no significant differences between groups after intervention in the primary outcome (P = 0.22; effect size=0.69); however, a tendency of improvement in wake after sleep onset (WASO) was observed (P = 0.07; effect size=0.81; B = 42.2). Both groups presented better sleep quality over time (AG P < 0.001; PG P = 0.011). AG participants showed a significant decrease in sleep onset latency (P = 0.001), depression levels (P = 0.025), hot flashes (P < 0.001), postmenopausal symptoms (P < 0.001) and, in polysomnography data, increased sleep efficiency (P = 0.002) compared to baseline.ConclusionAlthough no significant differences were observed between groups, our data presented a tendency of improvement in WASO. Moreover, AG participants had enhanced overall sleep pattern, quality and sleep efficiency. Weekly follow-up and sleep hygiene instructions were essential for both groups to show improvement in almost all outcomes.Clinical trial registrationBrazilian Registry of Clinical Trials, www.ensaiosclinicos.gov.br, RBR-5q5t5z.     

The effect of self-affirmation on anxiety and perceived discomfort in patients who have undergone open-heart surgery. A randomized controlled trial

BackgroundSelf-affirmations help one focus on positive outcomes and adapt to new situations both psychologically and physiologically by the repetition of positive affirmation sentences. This method, which has promising results in symptom management, is predicted to have effective results in the management of pain and discomfort in patients undergoing open-heart surgery.AimTo investigate the effect of self-affirmation on anxiety and perceived discomfort in patients who have undergone open-heart surgery.MethodsThis study adopted a randomized controlled pretest-posttest follow-up research design. The study was conducted at a public training and research hospital (Istanbul, Turkey) specialized in thoracic and cardiovascular surgery. The sample consisted of 61 patients randomized into two groups: intervention (n = 34) and control (n = 27). The participants of the intervention group listened to a self-affirmation audio recording for three days after surgery. Anxiety levels and perceived discomfort regarding pain, dyspnoea, palpitations, fatigue and nausea were measured daily. The State Trait Anxiety Inventory (STAI) was used to measure the level of anxiety, meanwhile perceived discomfort regarding pain, dyspnoea, palpitations, fatigue and nausea were measured by a 0 to 10 Numeric Rating Scale (NRS).ResultsThe control group had significantly higher anxiety than the intervention group three days after surgery (P < 0.001). The intervention group had less pain (P < 0.01), dyspnoea (P < 0.01), palpitations (P < 0.01), fatigue (P < 0.001) and nausea (P < 0.01) than the control group.ConclusionsPositive self-affirmation helped reduce anxiety and perceived discomfort in patients who underwent open-heart surgery.ClinicalTrials.gov Identifier: NCT05487430.     

Relationship between Vitamin D levels and pain and disease activity in patients with newly diagnosed axial spondyloarthritis

ObjectivesTo explore the relationship between Vitamin D levels and pain and disease activity in patients with newly diagnosed axial spondyloarthritis (axSpA).MethodsA convenience sample of 131 newly diagnosed axSpA patients and 60 healthy controls was recruited from July 2016 to December 2018. Serum 25-hydroxyvitamin D [25(OH)D] was measured to assess vitamin D levels. Disease activity was assessed by objective indicators [Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), the Bath Ankylosing Spondylitis Metrology Index (BASMI)], patient-reported questionnaires [the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI)]. Pain intensity and interference were also assessed.ResultsVitamin D insufficiency [serum 25(OH) D levels<50 nmol/L]was found in 46 (35.1%) and 25 (43.3%) of the axSpA patients and the healthy controls, respectively. Female patients had higher risk (OR:4.928; 95% CI: 1.921–12.642) for vitamin D insufficiency than male patients. Vitamin D was positively correlated with CRP, ESR level, the BASFI, and the BASMI. Logistic regression showed that vitamin D levels were not associated with pain, or disease activity in the newly diagnosed axSpA patients. Gender was the only predictive variable for vitamin D levels.ConclusionsVitamin D insufficiency was prevalent in both newly diagnosed axSpA patients and healthy controls. There was no association between vitamin D and pain and disease activity in the newly diagnosed axSpA patients. Monitoring vitamin D levels is important and early intervention for vitamin D insufficiency is needed, especially in female patients.     

The respiratory effects of a Pilates method protocol: Randomized clinical trial

ObjectivesTo evaluate the respiratory effects of a Pilates method (PM) protocol in adult women.DesignSingle-blind randomized controlled trial.SettingsHealthy women were randomized into two groups using the Random.org online tool: a Pilates group (PG) (n = 33) and a control group (CG) (n = 29).ParticipantsSixty-two healthy women, aged 18–44 years, sedentary or irregularly active B (as defined by the international physical activity questionnaire [IPAQ]). The intervention consisted of 16 sessions of PM. protocol twice a week for the PG. The CG without intervention.Main outcomes measuresThe variables evaluated were maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), peak expiratory flow (PEF), tidal volume (TV), respiratory frequency (RF), minute volume (MV), and slow vital capacity (SVC).ResultsThe results showed significant evidence of the beneficial respiratory effects of the PM protocol when the PG was compared with the CG: increased MIP (p = 0.001), and a significant increase in TV (p = 0,047).ConclusionThe PM protocol used in this study may be effective for respiratory muscle strength because it improved MIP and TV.Clinical trial registrationhttps://ensaiosclinicos.gov.br/rg/RBR-5b6wc3.     

骨化三醇对维生素D缺乏2型糖尿病患者微量蛋白尿的影响

目的观察骨化三醇对维生素D缺乏的2型糖尿病患者微量蛋白尿的影响。方法2型糖尿病患者178例,依据25羟基维生素D（25-hydroxyvitamin D,25（OH）D）水平分为维生素D正常组（25（OH）D〉25μg／L）74例、维生素D不足组（25（0H）D15～25p.g／L）65例和维生素D缺乏组（25（OH）D〈15μg／L）46例。维生素D正常组给予常规规范化治疗控制血糖,维生素D不足和缺乏组在控制血糖治疗基础上给予骨化三醇0.5μg／次,1次／d,VI服,连续应用8周。比较3组治疗前及维生素D不足和缺乏组治疗后空腹血糖、糖化血红蛋白、总胆固醇、三酰甘油、高密度脂蛋白、低密度脂蛋白、高敏C反应蛋白、肌酐、血钙、肾小球滤过率、尿白蛋白排泄率。结果治疗前,维生素D不足组和维生素D缺乏组体质量指数、高敏c反应蛋白、尿白蛋白排泄率、肾小球滤过率均高于维生素D正常组（P〈0.05）;应用骨化三醇治疗后,维生素D不足组和维生素D缺乏组糖化血红蛋白、总胆固醇、高密度脂蛋白、低密度脂蛋白均较治疗前降低（P〈0.05）,尿白蛋白排泄率、空腹血糖、三酰甘油和肌酐较治疗前下降,但与治疗前比较差异无统计学意义（P〉0.05）。结论骨化三醇可在一定程度上降低2型糖尿病维生素D缺乏患者的尿蛋白排泄率、血脂水平。     

The impact of a cardiopulmonary resuscitation video on reducing surrogates' anxiety: A pilot randomized controlled trial

PurposeTo test the primary hypothesis that a CPR video will reduce ICU patients' surrogates' anxiety when deciding code status, as measured by the Hamilton Anxiety Rating (HAM-A) Scale, as compared to the no video group.Materials and methodsThis is a prospective randomized control trial. Twenty-seven ICU patients' surrogates were enrolled in the study after receiving an ICU team-led code status discussion. After the enrollment, twelve surrogates were randomized to the video group and fifteen to the no video group. The primary outcome of anxiety was quantified using the HAM-A Scale. Demographic information, clinical data, and patients' provenance information (Home vs. Not Home) were collected. The patients' severity of illness was calculated using the Sequential Organ Failure Assessment (SOFA) Score.ResultsThe HAM-A score in the video group was 5.65 points lower than in the no video group ([β = −5.65, 95% CI −11.12 −0.18] P = 0.04). The statistically significant difference was maintained when adjusting for patients' SOFA Score and patients' provenance (P = 0.03).ConclusionCPR video used to supplement ICU team-led code status discussions reduced surrogates' anxiety, as compared to no video. Trial Registration: ClinicalTrials.gov Identifier NCT03630965.