NCT03615950

Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis

Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: —

Summary

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 It 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. The proposed work will address the following specific aims: Specific 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. Specific Aim 2: Evaluation of the effect of swallowed corticosteroids on growth velocity.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-08-06
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States