Randomized, double‐blind clinical trial, controlled with placebo, of the toxicology of chronic melatonin treatment

• DOI: 10.1034/j.1600-0633.2002.290401.x
• Publication Date: 2003-03-12T08:30:58Z
• Authors: Maria de Lourdes ...; Magda Bignotto; Luciano R. Pinto Jr.; Sergio Tufik
• Keywords: Aspartate transaminase; Transaminase

The objective of the present study was to assess toxicology melatonin (10 mg), administered for 28 days 40 volunteers randomly assigned groups receiving either (N=30) or placebo (N=10) in a double‐blind fashion. following measurements were performed: polysomnography (PSG), laboratory examinations, including complete blood count, urinalysis, sodium, potassium and calcium levels, total protein albumin, glucose, triglycerides, cholesterol, high‐density lipoprotein (HDL), low‐density (LDL), very (VLDL), urea, creatinine, uric acid, glutamic‐oxalacetic transaminase (GOT), glutamic‐pyruvate (GPT), bilirubin, alkaline phosphatase, gama‐glutamic (GGT), T3, T4, TSH, LH/FSH, cortisol, serum concentrations. In addition, Epworth Somnolence Scale (ESS) sleep diary (SD) also applied 1 wk before each PSG. asked about possible side effects (SE) that appeared during treatment. carried out according timetable: Visit 0, filling term consent inclusion criteria; 1, PSG, ESS, SD, concentrations; 2, concentrations, SE; 3, 4, SE, SD; 5, SE. Analysis PSG showed statistically significant reduction stage group. No other differences between obtained. we did not observe, parameters analyzed, any toxicological effect might compromise use at dose 10 mg period time utilized this study.