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

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ClinicalTrials.gov Identifier: NCT03615950
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief 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.


Condition or disease Intervention/treatment
Eosinophilic Esophagitis Diagnostic Test: Bone Mineral Density (DEXA) scan Diagnostic Test: Vitamin D Measurement Diagnostic Test: Height measurement Other: Assessment of medication compliance

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : October 1, 2020


Group/Cohort Intervention/treatment
Intervention Group
30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.
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.

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.




Primary Outcome Measures :
  1. Effects of swallowed corticosteroids on bone mineral density [ Time Frame: 12 months ]
    Change in bone mineral density over 1 year while being treated with swallowed corticosteroids compared to age-matched controls


Secondary Outcome Measures :
  1. Effects of swallowed corticosteroids on linear growth [ Time Frame: 12 months ]
    Changes in linear growth over 1 year while being treated with swallowed corticosteroids compared to controls



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male and Female children, 5-12 years of age are eligible. Controls are age and gender matched to those in the intervention group
Sampling Method:   Non-Probability Sample
Study Population
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615950


Contacts
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Contact: Robbie Pesek, MD 5013641060 rdpesek@uams.edu
Contact: April Hickman 5013641060 AMHickman@uams.edu

Locations
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United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Robbie Pesek    501-364-1060    rdpesek@uams.edu   
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas

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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03615950     History of Changes
Other Study ID Numbers: ACHEOEBMD
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents