Adjunctive active vitamin D (AVD) decreases kidney function during treatment of secondary hyperparathyroidism (SHPT) with extended-release calcifediol (ERC) in non-dialysis chronic kidney disease (ND-CKD).

Introduction: Sustained 30% reductions of intact parathyroid hormone (iPTH) with ERC are associated with slower decline in estimated glomerular filtration rate (eGFR) in ND-CKD patients with SHPT. Such iPTH reductions usually require elevation of serum total 25-hydroxyvitamin D (25D) to ≥50 ng/mL, but achieving these reductions can be limited by the ERC dose ceiling (60 μg/day), raising the question of whether adjunctive (adj) AVD might be appropriate to further reduce iPTH.

Methods: This randomized controlled trial (RCT) examined whether adj AVD could safely increase iPTH reductions achieved with ERC and further reduce the rate of eGFR decline in 78 ND-CKD adults treated with ERC for 38 weeks.

Adjustable wind selectivity in shearwaters implies knowledge of the foraging landscape.

Understanding the movements of highly mobile animals is challenging because of the many factors they must consider in their decision-making. Many seabirds, for example, are adapted to use winds to travel long distances at low energetic cost but also potentially benefit from targeting specific foraging hotspots. To investigate how an animal makes foraging decisions, given the inevitable trade-off between these factors, we tracked over 600 foraging trips of breeding Manx shearwaters (Puffinus puffinus; N = 218 individuals) using GPS accelerometers.

Extended-Release Calcifediol: A Data Journey from Phase 3 Studies to Real-World Evidence Highlights the Importance of Early Treatment of Secondary Hyperparathyroidism.

Background: Early secondary hyperparathyroidism (SHPT) diagnosis and treatment are crucial to delay the progression of SHPT and related complications, in particular, cardiovascular events and bone fractures. Extended-release calcifediol (ERC) has been developed for the treatment of SHPT in patients with stage 3/4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI).

Summary: This review compares baseline characteristics and treatment responses of SHPT patients receiving ERC in phase 3 studies with those treated with ERC in a real-world study.

Flying fast improves aerodynamic economy of heavier birds.

A paradox of avian long-distance migrations is that birds must greatly increase their body mass prior to departure, yet this is presumed to substantially increase their energy cost of flight. However, here we show that when homing pigeons flying in a flock are loaded with ventrally located weight, both their heart rate and estimated energy expenditure rise by a remarkably small amount. The net effect is that costs per unit time increase only slightly and per unit mass they decrease.

How birds dissipate heat before, during and after flight.

Animal flight uses metabolic energy at a higher rate than any other mode of locomotion. A relatively small proportion of the metabolic energy is converted into mechanical power; the remainder is given off as heat. Effective heat dissipation is necessary to avoid hyperthermia.

Evaluation of Therapies for Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Chronic Kidney Disease.

Introduction: Parathyroid hormone-lowering responses after administration of three different therapies capable of raising serum total 25-hydroxyvitamin D (25OHD) were evaluated in patients with secondary hyperparathyroidism (SHPT), vitamin D insufficiency (VDI), and stage 3 or 4 chronic kidney disease (CKD).

Methods: Sixty-nine adult subjects with intact parathyroid hormone (iPTH) ≥85 and <500 pg/mL and VDI (25OHD <30 ng/mL) were randomized after ≥4-week washout to 2 months of open-label treatment with: (1) extended-release calcifediol (ERC) 60 μg/day; (2) immediate-release calcifediol (IRC) 266 μg/month; (3) high-dose cholecalciferol (HDC) 300,000 IU/month; or (4) paricalcitol plus low-dose cholecalciferol (PLDC) 1 or 2 μg and 800 IU/day, used as reference hormone replacement therapy. Serum 25OHD, calcium (Ca), phosphorus (P), plasma iPTH, and adverse events were monitored weekly.

Jackson Heart Study: Aggregate cardiovascular disease risk and auditory profiles.

Objectives: Evaluate the relationship between cardiovascular disease (CVD) risk factors and cochlear function in African Americans.

Methods: Relationships between hearing loss, cochlear function, and CVD risk factors were assessed in a cross-sectional analysis of 1106 Jackson Heart Study participants. Hearing loss was defined as puretone average (PTA) > 15 dB HL.

Factors in nephrologists' decision to treat pre-dialysis CKD patients with vitamin D insufficiency and SHPT: A discrete choice experiment.

Little is known about the most important factors that inform a nephrologist's decision to treat (DTT) pre-dialysis chronic kidney disease (CKD) patients with vitamin D insufficiency (VDI) and secondary hyperparathyroidism (SHPT). The objective of this study was to identify such factors and their relative importance in the DTT with a vitamin D therapy. A web-based, adaptive design conjoint analysis discrete-choice survey was developed to study factors that informed the DTT among a sample of 200 nephrologists located throughout the United States.

REsCue trial: Randomized controlled clinical trial with extended-release calcifediol in symptomatic COVID-19 outpatients.

Objectives: This double-blind randomized controlled trial investigated raising serum 25-hydroxyvitamin D (25D) with extended-release calcifediol (ERC) on time to symptom resolution in patients with mild to moderate COVID-19.

Methods: COVID-19 outpatients received oral ERC (300 mcg on days 1-3 and 60 mcg on days 4-27) or placebo (NCT04551911). Symptoms were self-reported daily.

Real-world assessment: effectiveness and safety of extended-release calcifediol and other vitamin D therapies for secondary hyperparathyroidism in CKD patients.

Introduction: Extended-release calcifediol (ERC), active vitamin D hormones and analogs (AVD) and nutritional vitamin D (NVD) are commonly used therapies for treating secondary hyperparathyroidism (SHPT) in adults with stage 3-4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI). Their effectiveness for increasing serum total 25-hydroxyvitamin D (25D) and reducing elevated plasma parathyroid hormone (PTH), the latter of which is associated with increased morbidity and mortality, has varied across controlled clinical trials. This study aimed to assess real-world experience of ERC and other vitamin D therapies in reducing PTH and increasing 25D.

Extended-Release Calcifediol Effectively Raises Serum Total 25-Hydroxyvitamin D Even in Overweight Nondialysis Chronic Kidney Disease Patients with Secondary Hyperparathyroidism.

Introduction: Obesity increases the risk of vitamin D insufficiency, which exacerbates secondary hyperparathyroidism in chronic kidney disease. Recent studies suggest that serum total 25-hydroxyvitamin D (25OHD) levels of ≥50 ng/mL are necessary to produce significant reductions in elevated parathyroid hormone levels in nondialysis patients. Data from real-world and randomized controlled trials (RCTs) involving these patients were examined for (1) relationships between vitamin D treatments and the achieved levels of serum 25OHD and between serum 25OHD and body weight (BW)/body mass index (BMI); and (2) the impact of BW/BMI on achieving serum 25OHD levels ≥50 ng/mL with extended-release calcifediol (ERC) treatment or vitamin D supplementation (cholecalciferol or ergocalciferol).

Central Auditory Processing and the Relationship to Perceived Hearing Difficulty: The Jackson Heart Study.

Objective: There are limited population-based studies of central auditory processing (CAP). We aimed to determine the relationship between CAP measures and perceived hearing difficulty (PHD) despite normal pure-tone audiometry in an African-American population.

Study Design: Cross-sectional.

Executive Summary of Clinical Practice Guideline on Tympanostomy Tubes in Children (Update).

Objective: This executive summary of the guideline update provides evidence-based recommendations for patient selection and surgical indications for managing tympanostomy tubes in children. The summary and guideline are intended for any clinician involved in managing children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes in any care setting as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals.

Clinical Practice Guideline: Tympanostomy Tubes in Children (Update).

Objective: Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. All these conditions are encompassed by the term (middle ear inflammation).

Real-World Assessment: Clinical Effectiveness and Safety of Extended-Release Calcifediol.

Introduction: The safety and efficacy of extended-release calcifediol (ERC) as a treatment for secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI) has been demonstrated in prospective randomized clinical trials (RCTs). ERC (Rayaldee®) was approved by the Food and Drug Administration in 2016 on the basis of these prospective RCTs. The current retrospective study assessed the postlaunch data available with respect to ERC's efficacy and safety in increasing serum 25-hydroxyvitamin D (25D) and reducing parathyroid hormone (PTH) in the indicated population.

Association Between Cardiometabolic Factors and Dizziness in African Americans: The Jackson Heart Study.

Background: Balance dysfunction is a complex, disabling health condition that can present with multiple phenotypes and etiologies. Data regarding prevalence, characterization of dizziness, or associated factors is limited, especially in an African American population.

Purpose: The aim of the study is to characterize balance dysfunction presentation and prevalence in an African American cohort, and balance dysfunction relationship to cardiometabolic factors.

Stroke risk in African Americans with subclinical auditory dysfuntion evidenced by Distortion Product Otoacoustic Emissions: the Jackson heart study.

Distortion product otoacoustic emissions (DPOAEs) are sensitive to early indices of cochlear pathology. Pathology to the cochlea is in part mediated by ischaemic related mechanisms. We propose that DPOAEs may provide an objective measure of cardiovascular risk.

Relationship of Overall Cardiovascular Health and Hearing Loss in The Jackson Heart Study Population.

Objectives: To evaluate the relationships among the overall cardiovascular health scoring tool, Life's Simple 7 (LS7), and hearing in an African-American cardiovascular study cohort.

Methods: Using the Jackson Heart Study's cohort of African Americans, the relationships between the LS7 scoring metric and hearing of 1314 individuals were assessed. Standard audiometric data was collected and hearing loss was defined as a four-frequency average of 500, 1000, 2000, and 4000 Hz greater than 25 dBHL (PTA4).

Genome-wide association meta-analysis identifies five novel loci for age-related hearing impairment.

Previous research has shown that genes play a substantial role in determining a person's susceptibility to age-related hearing impairment. The existing studies on this subject have different results, which may be caused by difficulties in determining the phenotype or the limited number of participants involved. Here, we have gathered the largest sample to date (discovery n = 9,675; replication n = 10,963; validation n = 356,141), and examined phenotypes that represented low/mid and high frequency hearing loss on the pure tone audiogram.

Tackling the Tibetan Plateau in a down suit: insights into thermoregulation by bar-headed geese during migration.

Birds migrating through extreme environments can experience a range of challenges while meeting the demands of flight, including highly variable ambient temperatures, humidity and oxygen levels. However, there has been limited research into avian thermoregulation during migration in extreme environments. This study aimed to investigate the effect of flight performance and high altitude on body temperature () of free-flying bar-headed geese (), a species that completes a high-altitude trans-Himalayan migration through very cold, hypoxic environments.

The Fertilized Anterior Cruciate Ligament: An All-Inside Anterior Cruciate Ligament Reconstruction Augmented With Amnion, Bone Marrow Concentrate, and a Suture Tape.

There is increasing research and interest surrounding biologics and sports medicine. Amnion has the potential to decrease adhesions and possibly protect anterior cruciate ligament (ACL) grafts along with increasing vascularization by acting as a scaffold. Bone marrow concentrate containing mesenchymal stem cells combined with Allosync Pure (Arthrex, Naples, FL) injected into ACL tunnels has the potential to increase the speed and quality of graft bone incorporation, especially when used in the setting of a soft-tissue allograft.