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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03615950
• Date of registration: 24/07/2018
• Prospective Registration: Yes
• Primary sponsor: Arkansas Children's Hospital Research Institute
• Public title: Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis
• Scientific title: Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis
• Date of first enrolment: October 1, 2019
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03615950
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Robbie Pesek, MD

• Name: Robbie Pesek

Key inclusion & exclusion criteria

Inclusion Criteria:

- Intervention:

1. Age 5-12 years

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

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.

- Controls:

1. Age 5-12 years

2. Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE

3. Not treated with swallowed corticosteroids

Exclusion Criteria:

- Intervention and controls:

1. Non-English speaking

2. Patients actively taking systemic corticosteroids or previous use of systemic
corticosteroids within the past 6 months

3. Patients actively taking inhaled corticosteroids or prior use of inhaled
corticosteroids in the 6 months prior to screening

4. Current or previous treatment with swallowed corticosteroids for EoE at the time
of screening

5. Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).



Age minimum: 5 Years
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Diagnostic Test: Bone Mineral Density (DEXA) scan

Diagnostic Test: Height measurement

Diagnostic Test: Vitamin D Measurement

Other: Assessment of medication compliance

Primary Outcome(s)

Effects of swallowed corticosteroids on bone mineral density [Time Frame: 12 months]

Secondary Outcome(s)

Effects of swallowed corticosteroids on linear growth [Time Frame: 12 months]

Secondary ID(s)

ACHEOEBMD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Arkansas