Anti-Folic Acid monoclonal antibody, clone GB3

Objectives: Little is known about the interactions between hyperhomocysteinemia and metabolic syndrome (MetS) in individuals at risk for atherosclerosis. The aim of this study was to assess the burden of atherosclerosis in patients with MetS and hyperhomocysteinemia. Methods: We assessed the interaction of MetS with other risk factors including hyperhomocysteinemia in 972 patients with a history of stroke, transient ischemic attack, or carotid stenosis. MetS was defined as by the International Diabetes Federation as body mass index >30 kg/m2 and two or more of the following: hypertension, high triacylglycerides, and low high-density lipoprotein. We defined hyperhomocysteinemia as plasma total homocysteine >14 mmol/L. Patients with diabetes were excluded. Carotid total plaque area (TPA), a strong predictor of cardiovascular risk, was measured by carotid ultrasound. The association of TPA with MetS, and interaction with related risk factors, was assessed by multiple linear regression. Results: Complete data were available on 972 non-diabetic patients. Of these, 179 (18.4%) had MetS. Patients with MetS and hyperhomocysteinemia (P < 0.001) or smoking (P = 0.02) had a higher TPA compared with those with MetS and normal plasma total homocysteine levels. In linear regression, there was a significant association of MetS (P = 0.004), hyperhomocysteinemia (P = 0.01), and smoking (P = 0.004) with increased TPA. Conclusions: Patients with MetS and smoking or hyperhomocysteinemia are at particularly high cardiovascular risk. Targeted atherosclerosis prevention should include identification and treatment of MetS, smoking, and hyperhomocysteinemia (including that due to unrecognized metabolic vitamin B12 deficiency). (C) 2020 Elsevier Inc. All rights reserved.

ObjectivesThis study will evaluate the main hypothesis that supplementation with vitamins A, B, C, D, and E significantly improves the severity and mortality rate in ICU patients with COVID-19.Trial designThis study is a randomized, single-blinded, two-arm (1:1 ratio) parallel group clinical trial.ParticipantsWe are conducting this study in patients with COVID-19 admitted to intensive care units at the Imam Khomeini Hospital Complex in Tehran, Iran.The inclusion criteria are as follows: (1) aged between 20 and 60years, (2) both male and female patients with COVID-19, (3) clinical or definitive diagnosis (using polymerase chain reaction (PCR) test), (4) patients have not participated in other clinical trials, and (5) no renal or hepatic abnormalities.The exclusion criteria are as follows: (1) patients with specific and rare viral diseases such as HIV and (2) patients who have been undergoing chemotherapy for the past month.Intervention and comparatorDuration of intervention: 7days from randomizationIntervention in the treatment group: Vitamin A 25,000IU dailyVitamin D 600,000IU once during studyVitamin E 300IU twice dailyVitamin C is taken four times per dayB vitamins are taken as a daily Soluvit [which included thiamine nitrate 3.1mg, sodium riboflavin phosphate 4.9mg (corresponding to vitamin B2 3.6mg), nicotinamide 40mg, pyridoxine hydrochloride 4.9mg (corresponding to vitamin B6 4.0mg), sodium pantothenate 16.5mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113mg (corresponding to vitamin C 100mg), biotin 60 mu g, folic acid 400 mu g, and cyanocobalamin 5 mu g]The control group will not receive any supplements or placebo.All supplements are made in Iran except for Soluvit (from Fresenius Kabi, New Zealand).Main outcomes list list-type="order">Weight, height, and BMISeverity of pulmonary involvement according to CT scanRespiratory support (invasive or non-invasive)Percentage of oxygen saturation (SpO2 level)Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-alpha The patient's body temperatureThe presence or absence of involvement of organs other than the lungs (e.g., heart, liver, kidneys)Duration of hospitalizationMortality rateRandomizationAt baseline, eligible patients were randomly assigned to a 1:1 ratio to one of two groups: intervention and control. Block randomization is used based on the gender of patients.Blinding (masking)Patients are unaware of being placed in the intervention or control groups after signing consent. All treatment staff will be aware of which group each of the patients is in due to the specific conditions of the ICU and the absence of placebo for the control group.Numbers to be randomized (sample size)The researchers plan to include 60 patients in total, with 30 patients in each group.Trial statusThis is the first version of the protocol which started on April 2, 2020. Recruitment began April 2, 2020, and is expected to be complete by July 4, 2020.Trial registrationThe Iranian Registry of Clinical Trials IRCT20200319046819N1. Registered on April 4, 2020Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol (Fig. 1, Table 1).