Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||5 Years - 12 Years|
- - Intervention: 1.
- - Controls: 1.
- - Intervention and controls: 1.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Arkansas Children's Hospital Research Institute|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
: Intervention Group
30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.
: Control Group
30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group.
Diagnostic Test: - Bone Mineral Density (DEXA) scan
Radiologic assessment of bone mineral density in the lumbar spine. This will be performed at screening. If abnormal at screening, subjects will not be enrolled. For enrolled subjects, DEXA will be repeated at 12 months.
Diagnostic Test: - Vitamin D Measurement
Measurement of 25-hydroxy vitamin D levels through the blood at baseline and 12 months. If low for age, subjects will receive dietary counseling to increase intake to recommended levels. Primary care providers of enrolled subjects will be notified of abnormal results.
Diagnostic Test: - Height measurement
Height will be measured at baseline and 12 months.
Other: - Assessment of medication compliance
Subjects enrolled in the intervention group will undergo assessment of compliance with swallowed corticosteroids prescribed by their clinical provider. This will be performed at 6 and 12 months.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.