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Melatonin & Ulcerative Colitis (Melatonin & UC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00790478
First received: November 12, 2008
Last updated: December 22, 2009
Last verified: February 2009
History of Changes
  Purpose

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
Ulcerative Colitis
 Dietary Supplement: Melatonin
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

Resource links provided by NLM:

Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790478

Contacts
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

Locations
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
  More Information

Publications:

Responsible Party: Paul Terry, Ph.D. , MPH, Department of Epidemiology, Emory University Rollins School of Public Health
ClinicalTrials.gov Identifier: NCT00790478     History of Changes
Other Study ID Numbers: 8173, IBD-0223
Study First Received: November 12, 2008
Last Updated: December 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Ulcerative Colitis
Melatonin
Gastrointestinal
 Irritable Bowel syndrome
Sleep
Pilot Study

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
 Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013