Melatonin & Ulcerative Colitis (Melatonin & UC)
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|ClinicalTrials.gov Identifier: NCT00790478|
Recruitment Status : Unknown
Verified February 2009 by Emory University.
Recruitment status was: Recruiting
First Posted : November 13, 2008
Last Update Posted : December 23, 2009
Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body functions that may be related to health. Melatonin is produced in the pineal gland and, in fact, it is produced in even greater amounts in the gut. Melatonin appears to be important in gastrointestinal tract physiology and health, and data from cell and animal experiments, and some studies in humans, suggest that supplemental melatonin may help ameliorate colitis. Given that current treatments for ulcerative colitis are not always effective, and often have serious side effects, there is considerable interest in finding alternative treatments for this disease. However, experimental data on the ability of melatonin to improve ulcerative colitis in humans are lacking. To address this, we plan to conduct a pilot clinical trial (60 adult male and female participants) that will obtain preliminary data about the effectiveness of melatonin supplementation as a treatment for ulcerative colitis in adult men and women with the disease.
The "Melatonin and Ulcerative Colitis" study funded by a grant from the Broad Foundation's Broad Medical Research Program (http://www.broadmedical.org).
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Dietary Supplement: Melatonin Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Melatonin and Ulcerative Colitis: A Pilot Clinical Trial|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||April 2010|
|Placebo Comparator: Placebo||
Study Placebo taken once daily, preferably an hour before bedtime, for 12 weeks.
|Active Comparator: Melatonin||
Dietary Supplement: Melatonin
Study Pill (5 mg/d) taken once daily, preferably an hour before bedtime, for 12 weeks.
- 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. [ Time Frame: April 2010 ]
- 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. [ Time Frame: April 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790478
|Contact: Paul D Terry, PhD, MPH||(404) firstname.lastname@example.org|
|Contact: Sharon M Pritchett, MPH||(404) email@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator: Paul D Terry, PhD, MPH|
|Atlanta, Georgia, United States|
|Principal Investigator: Paul Terry, PhD|