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Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

NCT00790478 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-02-12

Study results available
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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 (http://www.broadmedical.org).

Conditions

Interventions

DRUG

Melatonin

Study Pill (5 mg/d) taken once daily, preferably an hour before bedtime, for 12 weeks.

OTHER

Placebo

Study Placebo taken once daily, preferably an hour before bedtime, for 12 weeks.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00790478 on ClinicalTrials.gov