Effects of altitude and recombinant human erythropoietin on iron metabolism: a randomized controlled trial

2021 ◽  
Author(s):  
Andreas Breenfeldt Andersen ◽  
Thomas Christian Bonne ◽  
Jacob Bejder ◽  
Grace Jung ◽  
Tomas Ganz ◽  
...  
Keyword(s):  
Sea Level ◽  
Clinical Relevance ◽  
Recombinant Human Erythropoietin ◽  
Controlled Trial ◽  
Venous Blood ◽  
Early Assessment ◽  
Stress Erythropoiesis ◽  
Human Erythropoietin ◽  
The Impact

Current markers of iron deficiency (ID) such as ferritin and hemoglobin have shortcomings, and hepcidin and erythroferrone (ERFE) could be of clinical relevance in relation to early assessment of ID. Here, we evaluate whether exposure to altitude-induced hypoxia (2,320 m) alone, or in combination with recombinant human erythropoietin (rHuEPO) treatment, affects hepcidin and ERFE levels before alterations in routine ID biomarkers and stress erythropoiesis manifest. Two interventions were completed, each comprising a four-week baseline, a four-week intervention at either sea level or altitude, and a four-week follow-up. Participants (n=39) were randomly assigned to 20 IU·kg bw-1 rHuEPO or placebo injections every second day for three weeks during the two intervention periods. Venous blood was collected weekly. Altitude increased ERFE (P≤0.001) with no changes in hepcidin or routine iron biomarkers, making ERFE of clinical relevance as an early marker of moderate hypoxia. rHuEPO treatment at sea level induced a similar pattern of changes in ERFE (P<0.05) and hepcidin levels (P<0.05), demonstrating the impact of accelerated erythropoiesis and not of other hypoxia-induced mechanisms. Compared to altitude alone, concurrent rHuEPO treatment and altitude exposure induced additive changes in hepcidin (P<0.05) and ERFE (P≤0.001) parallel with increases in hematocrit (P<0.001), demonstrating a relevant range of both hepcidin and ERFE. A poor but significant correlation between hepcidin and ERFE was found (R2=0.13, P<0.001). The findings demonstrate that hepcidin and ERFE are more rapid biomarkers of changes in iron demands than routine iron markers. Finally, ERFE and hepcidin may be sensitive markers in an anti-doping context.

Recombinant Human Erythropoietin May Negatively Influence Survival in Newly Diagnosed Patients with Multiple Myeloma: A Single Center Experience in 246 Patients.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4814-4814
Author(s):  
Eirini Katodritou ◽  
Evgenia Verrou ◽  
Anastasia Banti ◽  
Vassiliki Gastari ◽  
Dimitra Mihou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Serum Creatinine ◽  
Serum Ferritin ◽  
Recombinant Human Erythropoietin ◽  
Newly Diagnosed ◽  
Human Erythropoietin ◽  
The Impact

Abstract Anemia is a common clinical problem in patients with multiple myeloma (MM), which adversely affects their quality of life. The administration of recombinant human erythropoietin (r-HuEPO) improves anemia in about 2/3 of patients. However, it has not been clarified if r-HuEPO has any beneficial or adverse impact on the overall survival, particularly in a clear population of MM patients. The aim of this study was to examine the impact of r-HuEPO administration on the overall survival of newly diagnosed patients with MM. Two hundred forty-six newly diagnosed symptomatic MM patients, 139 males and 107 females, with a median age of 67 years (range 29–90) were studied. R-HuEPO was administered according to standard criteria, when Hb levels were less than 10.5g/dl and it was titrated and discontinued when Hb level reached 13g/dl. The parameters evaluated for predicting survival were: Age, sex, Hb, platelets, bone marrow infiltration, serum creatinine, serum ferritin, ISS score, B2-microglobulin and r-HuEPO administration. Cox regression was used for the univariate and multivariate analysis. One hundred forty-two patients received r-HuEPO and 105 did not. The median duration of r-HuEPO administration was 6 weeks (range 4–10) and the median hemoglobin level of patients who received r-huEPO, was 9.2g/dl (range 7.3–10.5 g/dl). The median follow up was 31 months (range 1–231). The univariate analysis showed that, age, Hb, platelets, serum creatinine, serum ferritin, ISS score, B2-microglobulin and r-HuEPO administration predicted for survival (p<0.05). The multivariate analysis demonstrated that, age, ISS score and r-HuEPO administration were statistically significant for predicting overall survival (p<0.05). The median survival of patients in the r-HuEPO group was 22 months (SD 22.7mo) whereas in the group without r-HuEPO administration it was 40 months (SD 35.8mo) (p=0.02). These results, suggest that r-HuEPO administration may negatively influence overall survival in newly diagnosed patients with MM and therefore, within this context, it should be used with caution. The large number of exclusively MM patients with a long follow up included in this study, highlights the importance of these results.

Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Jaime Céspedes ◽  
German Briceño ◽  
Michael Farkouh ◽  
Rajesh Vedanthan ◽  
Martha Leal ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Educational Programs ◽  
Control Group ◽  
Active Lifestyle ◽  
And Control ◽  
The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

Effect of short term recombinant human erythropoietin (rHuEPO) therapy in the prevention of anemia of prematurity (AOP) in very low birth weight (VLBW) neonates

2013 ◽  
Vol 38 (3) ◽  
pp. 119-123 ◽  
Author(s):  
BHN Yasmeen ◽  
MAKA Chowdhury ◽  
MM Hoque ◽  
MM Hossain ◽  
R Jahan ◽  
...  
Keyword(s):  
Folic Acid ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Recombinant Human Erythropoietin ◽  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Control Group ◽  
Short Term ◽  
Human Erythropoietin ◽  
Anaemia Of Prematurity

Premature infants especially those with birth weight <1500 g suffer from Anaemia of prematurity (AOP) and associated problems. Erythropoietin therapy is a safe effective way to prevent and to treat anaemia of prematurity. To evaluate the effect of short term administration of recombinant human erythropoietin (rHuEPO) with iron and folic acid in very low birth weight (VLBW) neonates in the prevention of anaemia of prematurity. A randomized controlled trial was carried out at Dhaka Shishu Hospital. Sixty preterm very low birth weight (PTVLBW) babies were enrolled in this study. Thirty were assigned to rHuEPO group and 30 as control. Baseline haematologic values were estimated before administration of rHuEPO. From day 7 of life rHuEPO-200 IU/kg/dose subcutaneously every alternate day for 2 weeks was administered to rHuEPO group. All infants in both groups have received oral iron, folic acid from day 14. Clinical and haematological assessment was done at 6 and 10 weeks of life. Baseline clinical characteristics and haematologic values were almost similar in both groups. This study has shown increase in haematological values(haemoglobin and haematocrit) and reduction in the number of blood transfusions during both the 1st and 2nd follow up in rHuEPO group in comparison to control group (p<0.01). Short term rHuEPO appears to be very effective in prevention of Anaemia of prematurity. DOI: http://dx.doi.org/10.3329/bmrcb.v38i3.14340 Bangladesh Med Res Counc Bull 2012; 38(3): 119-123 (December)

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

Abstract Background : Older people are frequent Emergency Department (ED) users who present with complex issues that are linked to poorer health outcomes post-index visit, often have increased ED length of stay and tend to have raised healthcare costs. Encouraging evidence suggests that ED teams involving health and social care professionals (HSCPs) can contribute to enhanced patient flow and improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCPs teams assessing and intervening with older adults in the ED is limited and identifies important methodological limitations, highlighting the need for more robust and comprehensive investigations of this model of care. This study aims to evaluate the impact of a dedicated ED-based HSCP team on the quality, safety, clinical and cost-effectiveness of care of older adults when compared to usual care. Methods : The study is a single-site randomised controlled trial whereby patients aged ≥65 years who present to the ED of a large Irish hospital will be randomised to the experimental group (ED-based HSCP assessment and intervention) or the control group (usual ED care). The recruitment target is 320 participants. The HSCP team will provide a comprehensive functional assessment as well as interventions to promote a safe discharge for the patient. The primary outcome is ED length of stay (from arrival to discharge). Secondary outcomes include: rates of hospital admissions from the ED, ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days, four and six-month follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; costs-effectiveness in terms of costs associated with ED-based HSCP compared to usual care; and perceptions on implementation by ED staff members. Discussion : This is the first randomised controlled trial testing the impact of HSCPs working in teams in the ED on the quality, safety, clinical and cost-effectiveness of care for older patients. The findings of the study will provide important information on the effectiveness of this model of care for future implementation. Trial registration : ClinicalTrials.gov, NCT03739515; registered on 12 th November 2018. Protocol version 1. URL: https://clinicaltrials.gov/ct2/show/NCT03739515

scholarly journals HIV and other STIs self-testing to reduce risk compensation among men who have sex with men who use oral pre-exposure prophylaxis in China: protocol for a randomised waitlist-controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036231
Author(s):  
Jing Zhang ◽  
Xiaojie Huang ◽  
Yaokai Chen ◽  
Hui Wang ◽  
Yonghui Zhang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Sexual Partners ◽  
Risk Compensation ◽  
Standard Facility ◽  
Self Testing ◽  
Condomless Anal Intercourse ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
The Impact

IntroductionPre-exposure prophylaxis (PrEP) reduces the risk of HIV infection among men who have sex with men by up to 99%. However, in real-world settings, PrEP users may exhibit risk compensation after uptake of PrEP, including more condomless anal intercourse (CAI) and increased sexually transmitted infection (STI) acquisition. HIV self-testing (HIVST) decreases CAI among men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one’s sexual partners. Here, we describe the rationale and design of a randomised waitlist-controlled trial to examine the impact of HIVST on risk compensation among PrEP users.Methods and analysisThe study is a two-arm randomised waitlist-controlled trial with 1000 HIV-negative MSM in four major cities in China who will be taking oral PrEP (involving tenofovir disoproxil fumarate/emtricitabine) either daily (n=500) or in an event-driven regimen (n=500). The participants will be randomised (1:1) to either the immediate HIVST intervention arm (HIVST plus standard facility-based counselling and testing from 0 to 12 months) or the waitlist arm (standard facility-based counselling and testing from 0 to 6 months, then crossover to receive the HIVST intervention in months 7–12). Participants will provide blood samples to assess the incidence of syphilis and herpes simplex virus type 2 (HSV-2) during a follow-up. The primary outcomes will be the occurrence of CAI, number of sexual partners and incidence of syphilis and HSV-2 during a follow-up. The secondary outcomes will be the HIV and STI testing frequency and STI treatment adherence during a follow-up. The planned start and end dates for the study is 26 December 2018 and 31 December 2020.Ethics and disseminationThe Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273).Trial registration numberChiCTR1800020374

scholarly journals Imagery rescripting in non-clinical paranoia: a pilot study of the impact on key cognitive and affective processes

2019 ◽  
Vol 48 (1) ◽  
pp. 54-66 ◽  
Author(s):  
Katherine Newman-Taylor ◽  
Pamela McSherry ◽  
Lusia Stopa
Keyword(s):  
Repeated Measures ◽  
Controlled Trial ◽  
Evidence Base ◽  
Traumatic Memories ◽  
Repeated Measures Design ◽  
Affective Processes ◽  
Imagery Rescripting ◽  
The Impact ◽  
Memory Characteristics

AbstractBackground:Paranoia is often accompanied by distressing intrusions associated with traumatic memories, yet one of the best-evidenced interventions, imagery rescripting (IR), is not routinely offered. This is likely to be due to poor understanding of the effects of IR on postulated mechanisms of change as well as the absence of a robust evidence base.Aims:This study aimed to establish proof of principle that IR impacts key cognitive-affective processes associated with distressing intrusions – memory characteristics and self-representations – and level of paranoia.Method:We used a within-subject repeated measures design to examine the effect of single-session IR on memory characteristics (level of intrusions, vividness, distress, encapsulated belief strength, emotion intensity and frequency), self-representation variables, affect and paranoia. Fifteen participants were seen once before and once after the IR session, to gather baseline and follow-up data.Results:As predicted, participants reported reductions in memory characteristics, improved self-esteem and positive affect, and reduced negative affect and paranoia, with large effect sizes. These effects were maintained at follow-up.Conclusions:While a within-subject design is useful for initial exploration of novel interventions, controlled studies are needed to determine causality. This is the first study to examine mechanisms of IR in paranoia. A controlled trial is now warranted.

Sign in / Sign up

Export Citation Format

Share Document