Melatonin in Pediatric FD Population

December 21, 2020 updated by: Children's Mercy Hospital Kansas City

The Therapeutic Effect of Melatonin in Pediatric Patients With Functional Dyspepsia

There are two specific aims in this study.

Specific Aim 1: Determine if melatonin results in a higher grade of clinical response than does placebo in children with functional dyspepsia (FD).

Hypothesis: treatment of FD with melatonin will result in a higher grade of clinical response than will treatment with a placebo.

Specific Aim 2: Evaluate the relationship between changes in sleep and improvement in pain in pediatric patients with functional dyspepsia receiving melatonin.

Hypothesis: There will be no association between improvement in pain and improvement in sleep in children with functional dyspepsia receiving melatonin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recurrent abdominal pain is present in a significant proportion of the pediatric population at large. Often times, no clear organic cause for pain will be found, and these children are diagnosed with functional abdominal pain. Of the children with functional abdominal pain, many are classified as having functional dyspepsia (FD). Functional dyspepsia is defined as persistent or recurrent pain or discomfort centered in the upper abdomen (above the umbilicus) that is unrelated to a change in stool frequency or form and not exclusively relieved by defecation. There have been only a few placebo controlled trials of medications in children with abdominal pain and none in children specifically with functional dyspepsia and uninvestigated mucosal inflammation.

There is increasing evidence suggesting that melatonin plays a role in pain modulation. Melatonin is produced by the pineal gland and is recognized for its regulation of sleep and circadian functions. Less widely recognized is melatonin's production in other parts of the body; such as in the digestive system and in immune cells including mast cells. The total amount of melatonin in the digestive system exceeds that of the pineal gland and blood. Within the digestive tract, melatonin is produced in the enterochromaffin cells. It exerts both excitatory and inhibitory effects on the enteric nervous system as well as possessing anti-inflammatory and immunomodulatory properties. In a rat model of reflux esophagitis, melatonin demonstrated multiple effects on the esophageal mucosa. These included decreased lipid peroxidation (oxidative degradation of lipids in cell membranes which leads to cell damage), replenished superoxide dismutase and glutathione (improved defense of the mucosa), and decreased expression of T helper 1 cytokines (pro-inflammatory cytokines) while not altering anti inflammatory cytokines. These effects may account for the reduction in pain in adults with irritable bowel syndrome (IBS) and dyspepsia during a trial of melatonin therapy. In a study of adults with IBS in association with sleep disturbances, patients were given melatonin 3mg or placebo at bedtime for two weeks. Compared with the placebo group, the group who received melatonin had significantly lower mean abdominal pain scores while sleep parameters were not influenced. In a study of adults with functional dyspepsia, twelve weeks of melatonin (5 mg taken at bedtime) resulted in 56.6% of patients having complete resolution of symptoms and 30% having partial improvement, while only 6.7% of the patients who received placebo experienced any improvement in symptoms. Melatonin has not been previously studied in children with abdominal pain. Evaluation of its effects is warranted as melatonin would be a very safe and inexpensive alternative treatment.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients seen in the GI clinic with a diagnosis of functional dyspepsia as defined by Rome III criteria.
  • Persistent pain despite acid suppression at therapeutic doses for at least 4 weeks
  • Patients ages 8-17 years, inclusive.

Exclusion Criteria:

  • Patients currently using melatonin.
  • Patients who have previously had endoscopy.

  • Initiation of a treatment plan that includes one or more of the following medications in the last 4 weeks

    • Opiates
    • Tramadol
    • Gabapentin
    • Benzodiazepines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin

Melatonin

All participants will receive a 5 mg. dose of melatonin before bed for a period of two weeks during study period.
Dietary supplement: Melatonin
Comparison between melatonin and placebo (2 weeks each) with active and placebo crossover during the study period of 34-36 days.
Other Names:
  • Melatonin 5 mg.
Placebo Comparator: Placebo

Placebo

All participants will receive a placebo comparative in substance, color, and flavor, before bed for two weeks during the study.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of clinical response to Melatonin in children with functional dyspepsia
Time Frame: 35 days
The overall positive response rate (grade 3-5) will be compared between melatonin and placebo by the McNemar test.
35 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep in pediatric patients with functional dyspepsia receiving melatonin
Time Frame: 35 days
The mean sleep latency and mean sleep duration from sleep diary and actigraphy data will be compared between baseline and therapy for melatonin and placebo, respectively, using the paired Student's t test.
35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Katherine Sturgeon, MD, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14010042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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