Melatonin in Pediatric FD Population

NCT04684199 | Completed DMC

• 1 other identifier: 14010042
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyspepsia

Keywords

Functional Dyspepsia; Melatonin; Pain; Actigraphy and Pain

Outcome Measures

Primary Outcomes (1)

• Grade of clinical response to Melatonin in children with functional dyspepsia

  The overall positive response rate (grade 3-5) will be compared between melatonin and placebo by the McNemar test.

  35 days

Secondary Outcomes (1)

• Change in sleep in pediatric patients with functional dyspepsia receiving melatonin

  35 days

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

Comparison between melatonin and placebo (2 weeks each) with active and placebo crossover during the study period of 34-36 days.

Also known as: Melatonin 5 mg.

Melatonin

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64108, United States

Location

Related Publications (14)

• 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.

  PMID: 13534750 BACKGROUND

• 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.

  PMID: 10457047 BACKGROUND

• Shaffer SE, Sellman SB, Repucci AH, Hupertz VF, Czinn SJ, Boyle JT. Dyspepsia: Redefining chronic abdominal pain in children. Gastroenterology. 1992; 102:163A

  BACKGROUND

• 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.

  PMID: 19223003 BACKGROUND

• 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.

  PMID: 19963060 BACKGROUND

• 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.

  PMID: 17426465 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

• 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.

  PMID: 19067786 BACKGROUND

• Buck M. The Use of Melatonin in Children With Sleep Disturbances. Pediatr Pharm. 2003;9(11)

  BACKGROUND

• Kobayashi I, Hall B, Palmieri P. Acigraphy improves measurements of sleep functioning. Traumatic Stress Points. 2008 Mar Vol 22, Issue 2

  BACKGROUND

• 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.

  PMID: 22424706 BACKGROUND

• 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.

  PMID: 23721120 BACKGROUND

• 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.

  PMID: 7939118 BACKGROUND

• 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.

  PMID: 16670647 BACKGROUND

MeSH Terms

Conditions

Dyspepsia; Pain

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

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

Study Officials

• Katherine Sturgeon, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: December 24, 2020
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)