scholarly journals Effects of Grape Seed Proanthocyanidin Extract on Vascular Endothelial Function in Participants with Prehypertension: A Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2844 ◽  
Author(s):  
Tamami Odai ◽  
Masakazu Terauchi ◽  
Kiyoko Kato ◽  
Asuka Hirose ◽  
Naoyuki Miyasaka
Keyword(s):  
Dose Group ◽  
Grape Seed ◽  
High Dose Group ◽  
Controlled Study ◽  
High Dose ◽  
Vascular Endothelial ◽  
Vascular Endothelial Function ◽  
Double Blind ◽  
Grape Seed Proanthocyanidin ◽  
The Mean

This study aimed to investigate the effects of grape seed proanthocyanidin extract (GSPE) on blood pressure and vascular endothelial function in middle-aged Japanese adults with prehypertension. We conducted a randomized, double-blind, placebo-controlled study on 6 men and 24 women aged 40–64 years old. The participants were randomized to receive tablets containing either low-dose (200 mg/day) or high-dose (400 mg/day) GSPE, or placebo, for 12 weeks. Systolic and diastolic blood pressures (SBP and DBP, respectively), brachial flow-mediated dilation (FMD), and other cardiovascular parameters were measured before and after 4, 8, and 12 weeks of treatment. The mean SBP in the high-dose group significantly decreased by 13 mmHg after 12 weeks (P = 0.028), although FMD did not change. In an ad hoc analysis of non-smoking participants (n = 21), the mean SBP, DBP, stiffness parameter β, distensibility, incremental elastic modulus (Einc), and pulse wave velocity (PWV) also significantly improved in the high-dose group after 12 weeks. Changes in Einc and PWV from baseline to 12 weeks were significantly greater in the high-dose group than in the placebo group (Einc, P = 0.023; PWV, P = 0.03). GSPE consumption could help maintain vascular elasticity and normal blood pressure in this population.

Bioavailability and Safety of Vitamin D3 from Pizza Baked with Fortified Mozzarella Cheese: A Randomized Controlled Trial

2015 ◽  
Vol 76 (3) ◽  
pp. 109-116 ◽  
Author(s):  
Banaz Al-Khalidi ◽  
Winnie Chiu ◽  
Dérick Rousseau ◽  
Reinhold Vieth
Keyword(s):  
Vitamin D ◽  
Dose Group ◽  
Controlled Trial ◽  
High Dose Group ◽  
Secondary Outcome ◽  
High Dose ◽  
Mozzarella Cheese ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
25 Hydroxyvitamin D

Purpose: To assess the bioavailability and safety of vitamin D3 from fortified mozzarella cheese baked on pizza. Methods: In a randomized, double-blind trial, 96 apparently healthy, ethnically diverse adults were randomized to consume 200 IU or 28 000 IU vitamin D3 fortified mozzarella cheese with pizza once weekly for a total of 8 weeks. Blood and urine samples were collected at baseline (week 1) and final (week 10) visits for serum 25-hydroxyvitamin D and other biochemical measures. The primary outcome compared serum 25-hydroxyvitamin D between groups at 10 weeks. The secondary outcome evaluated the safety of vitamin D dosing protocol as measured by serum and urine calcium, phosphate, creatinine, and serum parathyroid hormone (PTH). Results: Serum 25-hydroxyvitamin D increased by 5.1 ± 11 nmol/L in the low-dose group (n = 47; P = 0.003), and by 73 ± 22 nmol/L in the high-dose group (n = 49; P < 0.0001). None of the subjects in either group developed any adverse events during the supplementation protocol. Serum PTH significantly decreased in the high-dose group only (P < 0.05). Conclusions: Vitamin D3 is safe and bioavailable from fortified mozzarella cheese baked on pizza.

Differential Dosing of Trazodone in Elderly Depressed Patients: A Study to Investigate Optimal Dosing

1986 ◽  
Vol 14 (5) ◽  
pp. 279-284 ◽  
Author(s):  
P K Mukherjee ◽  
A Davey
Keyword(s):  
Dose Group ◽  
Rating Scale ◽  
High Dose Group ◽  
High Dose ◽  
Base Line ◽  
Double Blind ◽  
Visual Analogue Scales ◽  
Initial Starting ◽  
Analogue Scales ◽  
Significant Superiority

We investigated the comparative efficacy and tolerance of two initial starting doses of trazodone in 20 elderly inpatients suffering from depressive illness. The first 2-week phase was double-blind. Patients received either 25 mg trazodone tds or 50 mg tds. After this time the study was open, the dose of trazodone being titrated from the initial starting dose to maximise efficacy and tolerance. Patients received study medication for a total of 6 weeks. Assessments for efficacy included the Hamilton Depression rating scale, Zung anxiety scale, visual analogue scales for depression, euphoria and tension, and global assesments of severity and improvement of condition. Tolerance was assessed by means of a checklist of symptoms and adverse effects. Assessments were performed at base line and at weekly or bi-weekly intervals thereafter. A total of 18 patients were included in the analysis. The Zung and visual analogue scales indicated significant superiority for the high-dose group at Week 2. The Hamilton ratings indicated significant superiority for the high-dose group at Week 6 with a strong trend in favour of the high dose group at Week 2. Measures of severity of illness and improvement indicated more rapid improvement over time in the high-dose group. The treatment was generally well tolerated and at no time did adverse events outweigh therapeutic benefit. The incidence of headache and nausea was more frequent in the high-dose group in the first 2 weeks. The group of elderly patients studied benefited from trazodone therapy initiated at a higher therapeutic dose. This dose (150 mg total daily) was well tolerated and proved effective over the course of 6 weeks' treatment.

scholarly journals A double-blind, placebo-controlled, randomized trial of PXT3003 for the treatment of Charcot–Marie–Tooth type 1A

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Shahram Attarian ◽  
Peter Young ◽  
Thomas H. Brannagan ◽  
David Adams ◽  
Philip Van Damme ◽  
...  
Keyword(s):  
Dose Group ◽  
Sensitivity Analyses ◽  
High Dose Group ◽  
High Dose ◽  
Double Blind ◽  
Charcot Marie Tooth ◽  
Charcot Marie Tooth Disease ◽  
Scale Total Score ◽  
Full Analysis ◽  
Tooth Disease

Abstract Background Charcot–Marie–Tooth disease type 1A (CMT1A) is a rare, orphan, hereditary neuromuscular disorder with no cure and for which only symptomatic treatment is currently available. A previous phase 2 trial has shown preliminary evidence of efficacy for PXT3003 in treating CMT1A. This phase 3, international, randomized, double-blind, placebo-controlled study further investigated the efficacy and safety of high- or low-dose PXT3003 (baclofen/naltrexone/D-sorbitol [mg]: 6/0.70/210 or 3/0.35/105) in treating subjects with mild to moderate CMT1A. Methods In this study, 323 subjects with mild-to-moderate CMT1A were randomly assigned in a 1:1:1 ratio to receive 5 mL of high- or low-dose PXT3003, or placebo, orally twice daily for up to 15 months. Efficacy was assessed using the change in Overall Neuropathy Limitations Scale total score from baseline to months 12 and 15 (primary endpoint). Secondary endpoints included the 10-m walk test and other assessments. The high-dose group was discontinued early due to unexpected crystal formation in the high-dose formulation, which resulted in an unanticipated high discontinuation rate, overall and especially in the high-dose group. The statistical analysis plan was adapted to account for the large amount of missing data before database lock, and a modified full analysis set was used in the main analyses. Two sensitivity analyses were performed to check the interpretation based on the use of the modified full analysis set. Results High-dose PXT3003 demonstrated significant improvement in the Overall Neuropathy Limitations Scale total score vs placebo (mean difference: − 0.37 points; 97.5% CI [− 0.68 to − 0.06]; p = 0.008), and consistent treatment effects were shown in the sensitivity analyses. Both PXT3003 doses were safe and well-tolerated. Conclusion The high-dose group demonstrated a statistically significant improvement in the primary endpoint and a good safety profile. Overall, high-dose PXT3003 is a promising treatment option for patients with Charcot–Marie–Tooth disease type 1A.

SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled study

Rheumatology ◽  
2021 ◽  
Author(s):  
Jing Li ◽  
Mengtao Li ◽  
Di Wu ◽  
Jiaxin Zhou ◽  
Shui-on Leung ◽  
...  
Keyword(s):  
B Cell ◽  
Phase Ii ◽  
Dose Group ◽  
Low Dose ◽  
Response Rate ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Acr20 Response ◽  
Acr20 Response Rate

Abstract Objective SM03, a novel chimaeric mAb specific to B cell-restricted antigen CD22, has been developed to treat RA and other B-cell-related diseases. This 24-week phase II randomized, double-blind, multi-dose, placebo-controlled study aimed to evaluate the efficacy and safety of SM03 in moderately-to-severely active RA patients in China. Methods One hundred and fifty-six patients on background MTX were randomized in a 1:1:1 ratio to receive a cumulative dose of 3600 mg (high dose, 600 mg × 6 infusions at weeks 0, 2, 4, 12, 14 and 16) or 2400 mg SM03 (low dose, 600 mg × 4 infusions at weeks 0, 2, 12 and 14) or the placebo. The primary outcome was the 24-week ACR 20% improvement criteria (ACR20) response rate. Safety was also assessed. Results The 24-week ACR20 response rate was significantly higher with high- (65.3%, P = 0.002) and low-dose SM03 (56.9%, P = 0.024) than with placebo (34.0%), but comparable between the high- and low-dose group. The rate of adverse events was not statistically different among the high-dose group (35.3%), the low-dose group (51.9%) and the placebo group (34.6%). Thirteen (12.6%) patients receiving SM03 reported treatment-emergent infections, including 3.9% patients in the high-dose group. No patients reported severe treatment-emergent infections or malignancies. Conclusions In active RA Chinese patients receiving background MTX, SM03 at a cumulative dose of both 2400 mg and 3600 mg is efficacious and well-tolerated throughout the 24 weeks of treatment. Moreover, SM03 has demonstrated a good safety profile. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT04192617.

Безопасностьометрия при непрерывной заместительной гормональной терапии 17b-эстрадиоло-эндопротезной заместительной гормональной терапии 17b-эстрадиолиин иниситисинисисиной

2021 ◽  
Vol 50 (3) ◽  
pp. 76-82
Author(s):  
C. Bergeron ◽  
A. Ferenczy
Keyword(s):  
Effective Dose ◽  
Dose Group ◽  
Low Dose ◽  
Endometrial Polyp ◽  
High Dose Group ◽  
High Dose ◽  
Double Blind ◽  
Proliferative Endometrium ◽  
Endometrial Proliferation

The aim of the study was to determine the endometrial safety of oral 17/3- oestradiol combined continuously with dydrogesterone in preventing endometrial proliferation. The low dose group comprised three 52-week (13 cycles of 28 days) studies (two of which were double blind) using a 17ft- о estradiol dose of 1 mg daily combined with dydrogesterone 2,5; 5; 10 or 20 mg daily. The high dose group comprised two 24-week double-blind studies using a 17ft-oestradiol dose of 2 mg daily combined with dydrogesterone 2,5; 5; 10 or 15 mg daily. Endometrial safety was verified by aspiration endometrial biopsies. Inadequate progestational response was defined as proliferative endometrium, endometrial polyp, hyperplasia and carcinoma. Endometrial protection was achieved with dydrogesterone at doses of 5 mg or higher combined with 1 or 2 mg 17^-oestradiol. So, 5 mg daily dydrogesterone appears to be the lowest effective dose to ensure endometrial safety in a continuous combined regimen with 1 or 2 mg 17p-oestradiol.

The Effect of Vitamin D Supplementation On Calcium Excretion in Thalassemia

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1029-1029
Author(s):  
Sadana Balachandar ◽  
Rachel Randolph ◽  
Dorothy A. Kleinert ◽  
Sujit Sheth ◽  
Patricia Giardina ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Dose Group ◽  
Vitamin D Supplementation ◽  
High Dose Group ◽  
Controlled Study ◽  
High Dose ◽  
Calcium Excretion ◽  
Urine Calcium ◽  
Number Of Patients

Abstract Abstract 1029 Purpose of study: Transfusion dependent thalassemia (TM) patients are routinely supplemented with vitamin D due to their increased risk of developing osteoporosis. Recent studies from North America have found that these patients have high rates of vitamin D “deficiency” and “insufficiency,” despite supplementation. The amount of vitamin D supplementation required to raise serum 25 hydroxy-vitamin D (25-OHD) to optimal levels is not known in these patients. Recent studies have linked 25-OHD levels to hypercalciuria and nephrolithiasis in patients with TM. The purpose of this study is to determine the effect of various doses of vitamin D supplementation on vitamin D stores and calcium excretion in TM patients. Description of project: Prospective, single-blind, placebo-controlled study of TM patients followed in the transfusion center at Weill Cornell/New York Presbyterian Hospital. Patients with 25-OHD concentrations between 15–29 ng/mL were eligible for this 3-month study. Subjects were assigned in a block type of enrollment to the “high dose” equivalent of 2,000 IU of vitamin D per day versus placebo. Results: 14 subjects were enrolled, with 8 assigned to the “high dose” group and 6 assigned to the placebo group. The “high dose” group consisted of 6 females, aged 15.2–45.5 years with an average baseline 25-OHD level of 22.4 ng/mL (15–26). The “placebo” group consisted of 4 females, aged 22.5–45.7 years with an average baseline 25-OHD level of 19.8 ng/mL (16–24). After the 3 month study period, hypercalciuria developed more frequently in those treated in the “high dose” group. In the placebo group, hypercalciuria was noted in 1/6 (16.7%) spot urine calcium/creatinine tests and 0/3 (0%) 24 hour urine calcium estimations. In the “high dose” group, the corresponding number of patients based on the same methods of testing were 5/8 (62.5%) and 2/5 (40%). No episodes of hypocalcemia, hypercalcemia or nephrolithiasis occurred in either group. Conclusion: Our findings suggest that “high dose” vitamin D supplementation results in higher rates of hypercalciuria in TM patients. Further studies are necessary to determine the optimal dose of vitamin D supplementation to minimize the risk of osteoporosis while preventing nephrolithiasis in TM patients. Disclosures: No relevant conflicts of interest to declare.

The effects of etomidate on cerebral metabolism and blood flow in a canine model for hypoperfusion

1991 ◽  
Vol 74 (2) ◽  
pp. 263-269 ◽  
Author(s):  
R. Tyler Frizzell ◽  
Yves J. Meyer ◽  
D. John Borchers ◽  
Bradley E. Weprin ◽  
Elizabeth C. Allen ◽  
...  
Keyword(s):  
Blood Flow ◽  
Dose Group ◽  
Low Dose ◽  
Cerebral Metabolism ◽  
Oxygen Extraction Fraction ◽  
Oxygen Extraction ◽  
High Dose Group ◽  
High Dose ◽  
Cerebral Oxygen ◽  
The Mean

✓ The effects of etomidate, a nonbarbiturate cerebral metabolic depressant, on cerebral metabolism and blood flow were studied in 29 dogs during cerebral hypoperfusion. Three groups of animals were studied during a 45-minute normotensive and a 30-minute hypotensive period: 10 control animals without etomidate, 11 animals receiving a 0.1-mg/kg etomidate bolus followed by an infusion of 0.05 mg/kg/min etomidate (low-dose group), and eight animals receiving doses of etomidate sufficient to suppress electroencephalographic bursts (high-dose group). The mean arterial pressure fell to similar levels (p < 0.05) during hypotension in all three groups (40 ± 5, 38 ± 3, and 27 ± 6 mm Hg, respectively). The mean cerebral oxygen extraction fraction rose (p < 0.05) from 0.23 ± 0.02 to 0.55 ± 0.08 in the five control animals tested and from 0.33 ± 0.02 to 0.53 ± 0.02 in the seven animals tested in the low-dose group, but did not increase (p > 0.05) in the four animals tested in the high-dose group (0.24 ± 0.03 to 0.23 ± 0.05). Mean cerebral blood flow levels decreased in all groups during hypotension (p < 0.05): 42 ± 3 to 21 ±4 ml/100 gm/min (52% ± 12% decrease) in the five animals tested in the control group, 60 ± 8 to 24 ± 6 ml/100 gm/min (56% ± 13% decrease) in the four animals tested in the low-dose group, and 55 ± 8 to 22 ± 3 ml/100 gm/min (60% ± 4% decrease) in the four animals tested in the high-dose group. In summary, the cerebral oxygen extraction fraction increased in the control animals and low-dose recipients during hypotension, suggesting the presence of threatened cerebral tissue. In contrast, the cerebral oxygen extraction did not change during hypotension when high-dose etomidate was administered. It is concluded that high-dose etomidate may preserve the cerebral metabolic state during hypotension in the present model.

Clinical effectiveness of high dose versus standard dose of meropenem in ventilator-associated pneumonia caused by multidrug-resistant bacteria: a randomized single-blind clinical trial

2020 ◽  
Vol 20 ◽  
Author(s):  
Mahila Monajati ◽  
Shahram Ala ◽  
Masoud Aliyali ◽  
Roya Ghasemian ◽  
Fatemeh Heidari ◽  
...  
Keyword(s):  
Success Rate ◽  
Sofa Score ◽  
Dose Group ◽  
Clinical Success ◽  
Standard Dose ◽  
Clinical Success Rate ◽  
High Dose Group ◽  
Resistant Bacteria ◽  
High Dose ◽  
Ventilator Associated Pneumonia

Background: Meropenem standard doses are based on the minimum inhibitory concentration of sensitive pathogens and the pharmacokinetic parameter of not critically ill patients. We compared the efficacy of high versus standard dose of meropenem in ventilator-associated pneumonia (VAP). Methods: 24 out of 34 eligible patients were randomized to receive meropenem 3 g q8h (high dose group, 11 patients) or 2 g q8h (standard dose group, 13 patients) as a 3h infusion. Primary outcome was considered as clinical success that was defined as stable hemodynamic, improved sequential organ failure assessment (SOFA) score, stable or improved PaO2/FiO2 after 7 days. A sputum culture was taken before intervention. Results: Clinical success rate was not significantly different between the high and standard dose group (54.5% vs. 38.5%, P= 0.431). There was a significant difference in reduction of clinical pulmonary infection score (CPIS) compared to high dose with standard group (P=0.038). SOFA score declined significantly in high dose group through the study (P=0.006). A shorter duration of VAP treatment was recorded in high dose group (P=0.061). We did not observe any significant adverse event related to meropenem. Acinetobacter spp. (34.8%), Klebsiella spp. (32.6%) and, Pseudomonas aeruginosa (19.5%) isolated more frequently from sputum cultures. Conclusion: Treatment with high dose of meropenem seems to be safe. However, it did not provide significantly higher clinical success rate in comparison with the standard dose, but could be considered as an appropriate empirical treatment in patients with severe infection due to reducing in SOFA and CPIS.

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