Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial.

BACKGROUND: Heart disease progression occurs in 30% of patients with chronic Trypanosoma cruzi infection. Supplementation with selenium (Se) in animal model of T. cruzi infection produced promising results. There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease. The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy. METHODS: The Selenium Treatment and Chagasic Cardiopathy trial is a superiority, double-blind, placebo-controlled, randomized clinical trial. The eligibility criteria are as follows: (1) a Chagas disease diagnosis confirmed by serology; (2) segmental, mild or moderate global left ventricular systolic dysfunction; and (3) age between 18 and 65 years. The exclusion criteria are as follows: (1) pregnancy, (2) diabetes mellitus, (3) tobacco use, (4) alcohol abuse, (5) evidence of nonchagasic heart disease, (6) depression, (7) dysphagia with evidence of food residues in the esophagus, (8) dysphagia with weight loss higher than 15% of usual weight in the last four months and/or (9) conditions that may result in low protocol adherence. The intervention will be 100 µg of sodium selenite once daily for 365 consecutive days compared to placebo. The following are the primary outcomes to be measured: (1) the trajectories of the left ventricular ejection fraction in the follow-up period; (2) reduction of heart disease progression rates, with progression defined as a 10% decrease in left ventricular ejection fraction; and (3) rate of hospital admissions attributable to dysrhythmia, heart failure or stroke due to Chagas disease. One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of 1:1. The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes. Both patients and health-care providers will remain blinded to the intervention groups during the 5 years of follow-up. DISCUSSION: If Se treatment reduces the progression of Chagas cardiopathy, the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost. TRIAL REGISTRATION: Clinical Trials.gov ID: NCT00875173 (registered 20 October 20 2008).

Prevalence of psychoactive drug use among medical students in Rio de Janeiro.

BACKGROUND: Drug use and abuse may hamper learning capabilities and the development of technical skills in medical students and, therefore, the quality of care offered to patients. The aim of this investigation was to estimate the prevalence of psychoactive drug use among medical students of public universities in Rio de Janeiro, Brazil, and to identify characteristics associated with substance use. METHOD: This was a cross-sectional investigation designed to include all medical students of four universities. The final sample included 1,054 students. Patterns of licit and illicit drug use (at least once in lifetime drug use, drug use in the last 30 days (LTD) and CAGE) before and during medical school were assessed by a multiple-choice, self-administered anonymous questionnaire. RESULTS: Alcohol abuse was more prevalent among male students from higher income families. Alcohol LTD use was more prevalent among male students with college-educated parents. Tobacco, cannabis and inhalant lifetime use was more prevalent among males and tranquillizer use among females. Tobacco, cannabis and tranquillizer lifetime use was more prevalent among students with divorced or dead parents. Inhalant lifetime use was more prevalent among students from higher income families. Students who had college-educated, divorced or dead parents or evidenced tobacco, cocaine or inhalant lifetime use were more prevalent among cannabis users. Male students from higher income families had higher prevalence of cocaine lifetime use. CONCLUSION: Substance use in this group of medical students is not widespread compared to rates reported for developed countries. Preventive efforts should focus on alcohol and cannabis use by medical students.