Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-04 @ 5:27 PM
Study NCT ID:
NCT03615950
Status:
WITHDRAWN
Last Update Posted:
2025-10-02
First Post:
2018-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015519', 'term': 'Bone Density'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}], 'ancestors': [{'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of swallowed corticosteroids on bone mineral density', 'timeFrame': '12 months', 'description': 'Change in bone mineral density over 1 year while being treated with swallowed corticosteroids compared to age-matched controls'}], 'secondaryOutcomes': [{'measure': 'Effects of swallowed corticosteroids on linear growth', 'timeFrame': '12 months', 'description': 'Changes in linear growth over 1 year while being treated with swallowed corticosteroids compared to controls'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis']}, 'descriptionModule': {'briefSummary': 'Eosinophilic esophagitis (EoE) is characterized by allergy-driven inflammation of the esophagus leading to a variety of gastrointestinal symptoms and increased healthcare utilization. While considered a rare disease, EoE is rapidly increasing in prevalence in the United States. Treatment options are limited and include dietary modifications with the elimination of suspected food triggers or pharmacological options including proton pump inhibitors (PPIs) and swallowed corticosteroids. Compliance to strict elimination diets is difficult thus many patients elect to use swallowed corticosteroids. Because nearly half of all EoE patients are treated with swallowed corticosteroids there is a growing concern regarding the long-term effects of this class of medication.4\n\nIt is known that oral corticosteroids can compromise bone mineral density and growth velocity5-7. Furthermore, there have been multiple studies exploring the relationship between inhaled corticosteroids (ICS) and endocrine effects in asthmatics. While the risk of ICS use is less compared to systemic corticosteroids, higher ICS doses do cause deleterious effects on growth and bone health8-11. Currently, there are no published studies examining the effect of swallowed corticosteroids on bone mineral density or growth velocity in patients with EoE. Given the route of administration, there may be more systemic absorption leading to a higher risk of long-term complications.\n\nThe proposed work will address the following specific aims:\n\nSpecific Aim 1: Assess effects of swallowed corticosteroids on bone mineral density (primary outcome) in children 5-12 years of age with EoE compared to age matched controls.\n\nSpecific Aim 2: Evaluation of the effect of swallowed corticosteroids on growth velocity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "We will recruit 30 children, ages 5-12 years, with eosinophilic esophagitis (EoE) and 30 age and sex-matched controls from the Arkansas Children's Hospital allergy clinic to participate in this prospective study. Controls will be age- and gender-matched in a 1:1 ratio with EoE subjects but will not be required to have a diagnosis of EoE. Control subjects will not be treated with swallowed corticosteroids.", 'genderDescription': 'Male and Female children, 5-12 years of age are eligible. Controls are age and gender matched to those in the intervention group', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intervention:\n\n 1. Age 5-12 years\n 2. Diagnosis of EoE based upon a peak eosinophil count of ≥ 15 eosinophils/high powered field (hpf) on at least one esophageal biopsy while on a minimum of 8 weeks of PPI therapy\n 3. Patient/Family has elected to start swallowed corticosteroids for the treatment of EoE with a minimum daily dose of at least 0.5 mg budesonide or 440 mcg fluticasone. The decision to start swallowed corticosteroids will be made based upon the judgement of the provider, potential subject, and family during a clinic visit and will not be part of the research procedures.\n* Controls:\n\n 1. Age 5-12 years\n 2. Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE\n 3. Not treated with swallowed corticosteroids\n\nExclusion Criteria:\n\n* Intervention and controls:\n\n 1. Non-English speaking\n 2. Patients actively taking systemic corticosteroids or previous use of systemic corticosteroids within the past 6 months\n 3. Patients actively taking inhaled corticosteroids or prior use of inhaled corticosteroids in the 6 months prior to screening\n 4. Current or previous treatment with swallowed corticosteroids for EoE at the time of screening\n 5. Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).'}, 'identificationModule': {'nctId': 'NCT03615950', 'briefTitle': 'Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis', 'orgStudyIdInfo': {'id': 'ACHEOEBMD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention Group', 'description': '30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.', 'interventionNames': ['Diagnostic Test: Bone Mineral Density (DEXA) scan', 'Diagnostic Test: Vitamin D Measurement', 'Diagnostic Test: Height measurement', 'Other: Assessment of medication compliance']}, {'label': 'Control Group', 'description': '30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group.', 'interventionNames': ['Diagnostic Test: Bone Mineral Density (DEXA) scan', 'Diagnostic Test: Vitamin D Measurement', 'Diagnostic Test: Height measurement']}], 'interventions': [{'name': 'Bone Mineral Density (DEXA) scan', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Vitamin D Measurement', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Height measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Height will be measured at baseline and 12 months.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Assessment of medication compliance', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Arkansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}