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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00790478 |
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 | Intervention | Phase |
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Ulcerative Colitis |
Dietary Supplement: Melatonin Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Melatonin and Ulcerative Colitis: A Pilot Clinical Trial |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator |
Other: Placebo
Study Placebo taken once daily, preferably an hour before bedtime, for 12 weeks.
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Melatonin: Active Comparator |
Dietary Supplement: Melatonin
Study Pill (5 mg/d) taken once daily, preferably an hour before bedtime, for 12 weeks.
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Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul D Terry, PhD, MPH | (404) 727-8715 | pdterry@sph.emory.edu |
Contact: Sharon M Pritchett, MPH | (404) 727-3218 | smpritc@sph.emory.edu |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 |
Responsible Party: | Department of Epidemiology, Emory University Rollins School of Public Health ( Paul Terry, Ph.D. , MPH ) |
Study ID Numbers: | 8173, IBD-0223 |
Study First Received: | November 12, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00790478 |
Health Authority: | United States: Food and Drug Administration |
Ulcerative Colitis Melatonin Gastrointestinal |
Irritable Bowel syndrome Sleep Pilot Study |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Irritable Bowel Syndrome Inflammatory Bowel Diseases |
Melatonin Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Antioxidants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Depressants Protective Agents Central Nervous System Agents Pharmacologic Actions |