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Melatonin & Ulcerative Colitis (Melatonin & UC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Emory University

Brief Summary:

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 (

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Melatonin Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Placebo Comparator: Placebo Other: 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-69 years.
  • Diagnosed with ulcerative colitis and currently experiencing a flare up of mild-moderate severity according to Mayo Scoring system (>=4 and <=10).
  • Has a regular GI physician(s).
  • Availability for 14 weeks after enrolling in the study.
  • Female patients of child bearing potential must be surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (i.e., abstinence, oral, intramuscular, or implanted hormonal contraception, 2-barrier methods such as condom, diaphragm or spermicide).

Exclusion Criteria:

  • Night shift workers; otherwise, inability to attend morning study visits.
  • Current severe colitis according to the Mayo Scoring System (>10) or requiring hospital admission, or current very mild colitis (<4).
  • Current supplemental intake of melatonin or currently using tobacco products.
  • Proctitis or Crohn's disease
  • Previous gastrectomy or small or large bowel resection
  • Malabsorption syndrome (e.g., pancreatic insufficiency).
  • History of large bowel resection for any reason.
  • Diagnosed narcotic or alcohol dependence.
  • On renal dialysis.
  • Active liver disease (a chronic condition or under current therapy)
  • Seizure disorders
  • Immune system disorders
  • Any history of hypo- or hyperparathyroidism.
  • Unable to be off aspirin for 7 days.
  • Use of systemic or rectal steroids in the past 8 weeks.
  • Have a history of allergy or hypersensitivity to melatonin.
  • History of bleeding disorder or current use of anticoagulant medication.
  • Current use of calcium channel blockers, anticonvulsants, sedatives, hypnotics, or psychotropic medications.
  • Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the following 6 months, or are currently taking hormone replacement therapy (HRT).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00790478

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Contact: Paul D Terry, PhD, MPH (404) 727-8715
Contact: Sharon M Pritchett, MPH (404) 727-3218

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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Paul D Terry, PhD, MPH         
Consultative Gastroenterology Recruiting
Atlanta, Georgia, United States
Principal Investigator: Paul Terry, PhD         
Sponsors and Collaborators
Emory University

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Responsible Party: Paul Terry, Ph.D. , MPH, Department of Epidemiology, Emory University Rollins School of Public Health Identifier: NCT00790478    
Other Study ID Numbers: 8173
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: February 2009
Keywords provided by Emory University:
Ulcerative Colitis
Irritable Bowel syndrome
Pilot Study
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants