Abstract P161: Randomized Trial Of Magnesium Glycinate Supplementation And Blood Pressure In Middle-aged Adults

Hypertension ◽  
2020 ◽  
Vol 76 (Suppl_1) ◽  
Author(s):  
Howard D Sesso ◽  
Trisha Copeland ◽  
Jennifer L Coates ◽  
Olubunmi A Solano ◽  
Allison Clar ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Controlled Trial ◽  
Short Term ◽  
Double Blind ◽  
Subgroup Analyses ◽  
History Of ◽  
Baseline Characteristics ◽  
Middle Aged Adults ◽  
Healthy Participants

Introduction: Magnesium (Mg) intake is inversely associated with BP and hypertension risk in observational studies. However, short-term randomized trials on seated BP have been inconsistent, with few studies measuring 24-h ambulatory BP (ABP). In addition, Mg glycinate, a more easily absorbed form of supplemental Mg, has been largely untested in randomized trials and may serve as a first-line approach for BP reduction among those with elevated, untreated, BP. Methods: We conducted a randomized, double-blind, placebo-controlled trial (NCT03688503) testing 480 mg/d of elemental Mg glycinate versus placebo for 12 weeks among 59 otherwise healthy participants aged 30-74 y with elevated seated BP (systolic BP (SBP) 120-149 mmHg and/or diastolic BP (DBP) 80-94 mmHg) and no history of anti-hypertensive medication use. At baseline, 6 weeks, and 12 weeks, we measured seated BP, monitored 24-h ABP, and collected blood samples. Our primary aim tested Mg glycinate on 12-week changes in seated BP and 24-h ABP, and subgroup analyses considered if sex, age, or baseline BP modified the effect of Mg on BP. Results: Baseline characteristics were equally distributed at randomization (mean age, 57.2 y; 58% men) with mean seated BP of 133.4/82.6 mmHg. Compliance was high (Mg, 87%; placebo, 96%). After 12 weeks, there was no significant effect of Mg glycinate versus placebo on seated SBP (-4.5 vs -1.6 mmHg from baseline; p=0.38) and DBP (-1.9 vs -0.9 mmHg from baseline; p=0.64), nor was there any significant effect on overall, daytime, or nighttime 24-h ambulatory SBP and DBP (all p>0.05). In subgroup analyses, the effect of Mg glycinate on seated SBP was suggestively, but non-significantly, stronger among those with baseline seated SBP ≥130 mmHg (-9.3 vs -2.7 mmHg; p=0.12; p, interaction=0.24) and among women (-9.7 vs -3.1 mmHg; p=0.26; p, interaction=0.29). Age, seated DBP, and mean 24-h ambulatory SBP and DBP did not modify the effects of Mg supplementation. Conclusions: A Mg glycinate supplement did not significantly reduce seated or 24-h BP in adults with elevated, untreated BP. Forthcoming analyses will expand on the role of serum and dietary Mg levels. Larger trials are warranted to elucidate possible effects of Mg glycinate on seated SBP among those with elevated BP and among women.

scholarly journals A Randomized, Placebo-controlled, Double-blind Pilot Study of Single-dose Humanized Anti-IL5 Antibody (Reslizumab) for the Reduction of Eosinophilia Following Diethylcarbamazine Treatment of Loa loa Infection

2020 ◽  
Author(s):  
Fanny Legrand ◽  
Jesica Herrick ◽  
Michelle Makiya ◽  
Roshan Ramanathan ◽  
Reagan Thompson ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Loa Loa ◽  
Double Blind ◽  
Interleukin 5 ◽  
Diethylcarbamazine Citrate ◽  
Baseline Characteristics ◽  
Eosinophil Activation

Abstract Background Diethylcarbamazine citrate (DEC) treatment of loiasis is complicated by adverse reactions that are correlated with the number of circulating microfilariae (mf). The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation. Methods To explore the role of IL-5 driven eosinophilia in post-DEC reactions, 8 adults with confirmed loiasis and <5000 mf/mL blood were enrolled in a randomized, double-blind, placebo-controlled trial of the humanized anti-IL-5 antibody, reslizumab, (1.0 mg/kg IV) administered 3 to 7 days prior to initiation of DEC treatment (9 mg/kg/day for 21 days). The primary endpoint was the reduction in absolute eosinophil count (AEC) during the first week of DEC treatment. Results Baseline characteristics were comparable between the two groups. Single dose reslizumab lowered the AEC by 77% prior to initiation of DEC therapy (vs. 12% in the placebo group, P < .05). More importantly, AEC remained below baseline in the first week of DEC treatment in all subjects who received reslizumab and in none of the placebo subjects. Mf clearance occurred within 2 days of initiation of DEC in all 7 mf-positive subjects. Mild to moderate adverse events were seen in all 8 subjects and were not significantly different between the groups. Conclusions In summary, although reslizumab was able to blunt peripheral eosinophilia post-DEC treatment in subjects with loiasis and had no effect on microfilarial clearance, the reduction in AEC appeared to have been insufficient to prevent post-treatment AEs.

The PRO MiSe trial: baseline data review and progress report

2004 ◽  
Vol 10 (3_suppl) ◽  
pp. S65-S72 ◽  
Author(s):  
Jerry S Wolinsky ◽  
Keyword(s):  
Statistical Power ◽  
Controlled Trial ◽  
Progressive Multiple Sclerosis ◽  
Progression Rate ◽  
Primary Progressive Multiple Sclerosis ◽  
Short Term ◽  
Double Blind ◽  
Significant Treatment ◽  
Disability Status ◽  
History Of

The PRO MiSe trial is a multinational, multicentre, double-blind, placebo -controlled trial evaluating the effects of glatiramer acetate treatment over 3 years in patients with primary progressive multiple sclerosis (PPMS). A total of 943 patients were enrolled, and all those remaining on-study had completed at least 24 months as of O ctober 2002. Baseline clinical and MRI character istics and select correlations are reported here. A total of 3.9% of patients exhibited confirmed relapse over 1904 patient-years of exposure, indicating success of efforts to exclude relapsing MS types. O f the 26.3% of patients who have prematurely withdrawn from the study, only 36% discontinued after meeting the study primary endpoint of disease progression. The progression rate in patients in the low Expanded Disability Status Scale (EDSS) stratum (3.0-5.0) observed thus far is markedly lower than the 50% annual progression rate estimate used for determining size and statistical power of the trial; progression was observed in 16.1% of patients with 12 months of study exposure. These early findings raise some concern about the ability of the trial to demonstrate a significant treatment effect, and suggest that the short-term natural history of PPMS may not be as aggressive as previously assumed.

scholarly journals ECMO in COVID-19—prolonged therapy needed? A retrospective analysis of outcome and prognostic factors

Perfusion ◽  
2021 ◽  
pp. 026765912199599
Author(s):  
Esther Dreier ◽  
Maximilian Valentin Malfertheiner ◽  
Thomas Dienemann ◽  
Christoph Fisser ◽  
Maik Foltan ◽  
...  
Keyword(s):  
Lung Compliance ◽  
Ecmo Support ◽  
Short Term ◽  
Single Center Study ◽  
Venovenous Extracorporeal Membrane Oxygenation ◽  
Baseline Characteristics ◽  
Ecmo Therapy ◽  
Vv Ecmo

Background: The role of venovenous extracorporeal membrane oxygenation (VV ECMO) in patients with COVID-19-induced acute respiratory distress syndrome (ARDS) still remains unclear. Our aim was to investigate the clinical course and outcome of those patients and to identify factors associated with the need for prolonged ECMO therapy. Methods: A retrospective single-center study on patients with VV ECMO for COVID-19-associated ARDS was performed. Baseline characteristics, ventilatory and ECMO parameters, and laboratory and virological results were evaluated over time. Six months follow-up was assessed. Results: Eleven of 16 patients (68.8%) survived to 6 months follow-up with four patients requiring short-term (<28 days) and seven requiring prolonged (⩾28 days) ECMO support. Lung compliance before ECMO was higher in the prolonged than in the short-term group (28.1 (28.8–32.1) ml/cmH2O vs 18.7 (17.7–25.0) ml/cmH2O, p = 0.030). Mechanical ventilation before ECMO was longer (19 (16–23) days vs 5 (5–9) days, p = 0.002) and SOFA score was higher (12.0 (10.5–17.0) vs 10.0 (9.0–10.0), p = 0.002) in non-survivors compared to survivors. Low viral load during the first days on ECMO tended to indicate worse outcomes. Seroconversion against SARS-CoV-2 occurred in all patients, but did not affect outcome. Conclusions: VV ECMO support for COVID-19-induced ARDS is justified if initiated early and at an experienced ECMO center. Prolonged ECMO therapy might be required in those patients. Although no relevant predictive factors for the duration of ECMO support were found, the decision to stop therapy should not be made dependent of the length of ECMO treatment.

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

scholarly journals Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial

2021 ◽  
Vol 8 (1) ◽  
pp. e000562
Author(s):  
Adriana Fabiola Romano-Munive ◽  
J Jesus García-Correa ◽  
Luis F García-Contreras ◽  
José Ramírez-García ◽  
Luis Uscanga ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Sterile Water ◽  
Endoscopic Retrograde ◽  
Double Blind ◽  
Registration Number ◽  
Baseline Characteristics ◽  
Randomised Controlled ◽  
Rectal Indomethacin

Background and study aimsPost-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.Patients and methodsThis multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.ResultsOf the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).ConclusionSpraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.Trial registration numberThis study was registered with ClinicalTrials.gov (NCT02959112).

Physical Development and Medical History of Children Who Were Treated Antenatally With Corticosteroids to Prevent Respiratory Distress Syndrome: A 10- to 12-Year Follow-up

PEDIATRICS ◽  
1990 ◽  
Vol 86 (1) ◽  
pp. 65-70 ◽  
Author(s):  
H. Smolders-de Haas ◽  
J. Neuvel ◽  
B. Schmand ◽  
p. E. Treffers ◽  
J. G. Koppe ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Medical History ◽  
Distress Syndrome ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Ophthalmological Examination ◽  
Double Blind ◽  
History Of

Potential side effects of antenatal administration of corticosteroids to prevent neonatal respiratory distress syndrome were studied in 10- to 12-year-old children whose mothers had participated in a randomized, double-blind, placebo-controlled trial of betamethasone. The children had a general physical examination; parents were interviewed about the medical history of their child with special attention to infectious diseases; growth data were collected; and a developmental neurological examination, an ophthalmological examination, and a lung function test were conducted. In the corticosteroid group significantly more hospital admissions because of infectious diseases during the first years of life were reported. On the other variables no differences between the corticoid and the placebo groups were found.

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