Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
To estimate treatment effect of 12 weeks of 5 mg/day supplementation with melatonin on UC remission, and to use the estimate of this effect and its variability to calculate the sample size needed for a presumably larger and more definitive trial.
Investigate whether responses to treatment vary according to certain other factors, such as age, sex, duration of disease, clinical symptoms, sleep duration and quality during the trial, and baseline endogenous melatonin.
18 Years to 69 Years (Adult, Senior)
Melatonin & UC
November 13, 2008
December 23, 2009
Emory University Atlanta, Georgia, United States
Consultative Gastroenterology Atlanta, Georgia, United States
† Study has passed its completion date and status has not been verified in more than two years.