Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2014-08-31
2015-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Melatonin
Melatonin
All participants will receive a 5 mg. dose of melatonin before bed for a period of two weeks during study period.
Melatonin
Comparison between melatonin and placebo (2 weeks each) with active and placebo crossover during the study period of 34-36 days.
Placebo
Placebo
All participants will receive a placebo comparative in substance, color, and flavor, before bed for two weeks during the study.
Placebo
Interventions
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Melatonin
Comparison between melatonin and placebo (2 weeks each) with active and placebo crossover during the study period of 34-36 days.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Persistent pain despite acid suppression at therapeutic doses for at least 4 weeks
* Patients ages 8-17 years, inclusive.
Exclusion Criteria
* 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
8 Years
17 Years
ALL
No
Sponsors
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Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Principal Investigators
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Katherine Sturgeon, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Locations
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Children's Mercy
Kansas City, Missouri, United States
Countries
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References
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APLEY J, NAISH N. Recurrent abdominal pains: a field survey of 1,000 school children. Arch Dis Child. 1958 Apr;33(168):165-70. doi: 10.1136/adc.33.168.165. No abstract available.
Rasquin-Weber A, Hyman PE, Cucchiara S, Fleisher DR, Hyams JS, Milla PJ, Staiano A. Childhood functional gastrointestinal disorders. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II60-8. doi: 10.1136/gut.45.2008.ii60.
Shaffer SE, Sellman SB, Repucci AH, Hupertz VF, Czinn SJ, Boyle JT. Dyspepsia: Redefining chronic abdominal pain in children. Gastroenterology. 1992; 102:163A
Ambriz-Tututi M, Rocha-Gonzalez HI, Cruz SL, Granados-Soto V. Melatonin: a hormone that modulates pain. Life Sci. 2009 Apr 10;84(15-16):489-98. doi: 10.1016/j.lfs.2009.01.024. Epub 2009 Feb 15.
Maldonado MD, Mora-Santos M, Naji L, Carrascosa-Salmoral MP, Naranjo MC, Calvo JR. Evidence of melatonin synthesis and release by mast cells. Possible modulatory role on inflammation. Pharmacol Res. 2010 Sep;62(3):282-7. doi: 10.1016/j.phrs.2009.11.014. Epub 2009 Dec 4.
Klupinska G, Poplawski T, Drzewoski J, Harasiuk A, Reiter RJ, Blasiak J, Chojnacki J. Therapeutic effect of melatonin in patients with functional dyspepsia. J Clin Gastroenterol. 2007 Mar;41(3):270-4. doi: 10.1097/MCG.0b013e318031457a.
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.
Lahiri S, Singh P, Singh S, Rasheed N, Palit G, Pant KK. Melatonin protects against experimental reflux esophagitis. J Pineal Res. 2009 Mar;46(2):207-13. doi: 10.1111/j.1600-079X.2008.00650.x. Epub 2008 Nov 28.
Buck M. The Use of Melatonin in Children With Sleep Disturbances. Pediatr Pharm. 2003;9(11)
Kobayashi I, Hall B, Palmieri P. Acigraphy improves measurements of sleep functioning. Traumatic Stress Points. 2008 Mar Vol 22, Issue 2
Meltzer LJ, Montgomery-Downs HE, Insana SP, Walsh CM. Use of actigraphy for assessment in pediatric sleep research. Sleep Med Rev. 2012 Oct;16(5):463-75. doi: 10.1016/j.smrv.2011.10.002. Epub 2012 Mar 15.
Cellini N, Buman MP, McDevitt EA, Ricker AA, Mednick SC. Direct comparison of two actigraphy devices with polysomnographically recorded naps in healthy young adults. Chronobiol Int. 2013 Jun;30(5):691-8. doi: 10.3109/07420528.2013.782312. Epub 2013 May 30.
Sadeh A, Sharkey KM, Carskadon MA. Activity-based sleep-wake identification: an empirical test of methodological issues. Sleep. 1994 Apr;17(3):201-7. doi: 10.1093/sleep/17.3.201.
Weiss MD, Wasdell MB, Bomben MM, Rea KJ, Freeman RD. Sleep hygiene and melatonin treatment for children and adolescents with ADHD and initial insomnia. J Am Acad Child Adolesc Psychiatry. 2006 May;45(5):512-519.
Other Identifiers
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14010042
Identifier Type: -
Identifier Source: org_study_id