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Melatonin in Pediatric FD Population

NCT04684199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-12-24

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Melatonin

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

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Katherine Sturgeon, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT04684199 on ClinicalTrials.gov