Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

NCT00790478 | Terminated Phase 2 Results DMC

• 2 other identifiers: IRB00008173IBD-0223
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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 (http://www.broadmedical.org).

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Melatonin; Gastrointestinal; Irritable Bowel syndrome; Sleep; Pilot Study

Outcome Measures

Primary Outcomes (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.

  April 2010

Secondary Outcomes (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.

  April 2010

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo -- lactose pill.

Other: Placebo

Melatonin

ACTIVE COMPARATOR

Melatonin

Drug: Melatonin

Interventions

Melatonin DRUG

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

Melatonin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Consultative Gastroenterology

Atlanta, Georgia, United States

Location

Related Publications (8)

• D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.

  PMID: 17258735 BACKGROUND

• von Gall C, Stehle JH, Weaver DR. Mammalian melatonin receptors: molecular biology and signal transduction. Cell Tissue Res. 2002 Jul;309(1):151-62. doi: 10.1007/s00441-002-0581-4. Epub 2002 May 18.

  PMID: 12111545 BACKGROUND

• Li JH, Yu JP, Yu HG, Xu XM, Yu LL, Liu J, Luo HS. Melatonin reduces inflammatory injury through inhibiting NF-kappaB activation in rats with colitis. Mediators Inflamm. 2005 Aug 31;2005(4):185-93. doi: 10.1155/MI.2005.185.

  PMID: 16192667 BACKGROUND

• Nosal'ova V, Zeman M, Cerna S, Navarova J, Zakalova M. Protective effect of melatonin in acetic acid induced colitis in rats. J Pineal Res. 2007 Apr;42(4):364-70. doi: 10.1111/j.1600-079X.2007.00428.x.

  PMID: 17439553 BACKGROUND

• Song GH, Leng PH, Gwee KA, Moochhala SM, Ho KY. Melatonin improves abdominal pain in irritable bowel syndrome patients who have sleep disturbances: a randomised, double blind, placebo controlled study. Gut. 2005 Oct;54(10):1402-7. doi: 10.1136/gut.2004.062034. Epub 2005 May 24.

  PMID: 15914575 BACKGROUND

• Maldonado MD, Calvo JR. Melatonin usage in ulcerative colitis: a case report. J Pineal Res. 2008 Oct;45(3):339-40. doi: 10.1111/j.1600-079X.2008.00584.x. Epub 2008 Mar 10. No abstract available.

  PMID: 18331546 BACKGROUND

• Lu WZ, Gwee KA, Moochhalla S, Ho KY. Melatonin improves bowel symptoms in female patients with irritable bowel syndrome: a double-blind placebo-controlled study. Aliment Pharmacol Ther. 2005 Nov 15;22(10):927-34. doi: 10.1111/j.1365-2036.2005.02673.x.

  PMID: 16268966 BACKGROUND

• Saha L, Malhotra S, Rana S, Bhasin D, Pandhi P. A preliminary study of melatonin in irritable bowel syndrome. J Clin Gastroenterol. 2007 Jan;41(1):29-32. doi: 10.1097/MCG.0b013e31802df84c.

  PMID: 17198061 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Irritable Bowel Syndrome

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Colonic Diseases, Functional

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Paul Terry
• Organization: University of Tennessee

pterry@utmck.edu

(865) 305-9341

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: January 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 12, 2021
• Results First Posted: February 12, 2021

Record last verified: 2021-02

Locations

US (2)