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Sponsor study identifier
observational
70
1 country
1
Study Start
October 20, 2020
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Background: Improvement in clinical care has resulted in longer life expectancy of children with intestinal failure (IF). However, recent data indicate that their body composition (BC) is abnormal with a relatively high fat mass (FM) and low fat free mass (FFM). Abnormal BC is linked to poor prognosis and increased length of hospital stay; yet BC is not assessed in pediatric clinical practice. Instead, growth charts which lack sensitivity to detect changes in BC are used. Physical activity (PA) is the most important predictor of FFM and increased PA contributes to decreased FM. Decreased PA in childhood is associated with increased FM and decreased FFM which are linked to diabetes and cardiovascular disease in adulthood. Dual-energy X-ray Absorptiometry (DXA) is considered the reference method for measuring BC in the clinical setting but it is expensive and not suitable for routine use. Bioelectrical Impedance Analysis (BIA) on the other hand is relatively inexpensive and non-invasive but needs to be validated for use in patients with IF. Objectives: 1) validate BIA against DXA as a clinical tool for monitoring changes in BC in children with IF, 2) quantify PA levels using activity counts from accelerometers and 3) assess strength. Design: 1-18 years, with IF followed by the intestinal rehabilitation program at SickKids. All subjects receiving a DXA for routine clinical monitoring are eligible. BIA and muscle strength will be measured in clinic. Demographic data and IF related factors including height, weight, PN prescription, age, diagnosis, bowel length and length of time off PN for those who have achieved enteral autonomy will be obtained. DXA measurement will be done by Diagnostic Imaging at SickKids. Patients will be fitted with an accelerometer to be worn for 7 days. Statistics: Differences between sexes will be assessed by t test. Relationship between PA and BC, and BC and muscular strength will be assessed by linear regression analysis. Agreement between DXA and BIA will be assessed using a Bland-Altman test. Significance will be set at p\<0.05. Significance: This study has the potential to establish BIA as a convenient clinical tool to assess BC and provide a more accurate basis for nutritional and PA prescriptions to optimize long-term outcomes and quality of life in IF patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2020
Actual (reported)October 20, 2020
Actual (reported)November 2, 2020
Actual (reported)December 31, 2022
Actual (reported)December 31, 2022
Actual (reported)Body composition of children with intestinal failure compared with healthy controls.
measurement of fat and fat-free mass by BIA and DXA
11/1 2020 - 10/1/2023
To measure physical activity and strength of children with intestinal failure compared with healthy controls.
11/1 2020 - 10/1/2023
DXA BIA Skin fold measurements Strength tests Physical activity monitoring
BIA Skin fold measurements Strength tests Physical activity monitoring
Patients with Intestinal failure (IF) which is the inability of the gastrointestinal tract to absorb adequate fluid and nutrients for growth and maintenance due to disease associated loss of absorption.
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Yanchis D, So S, Patterson C, Belza C, Garofalo E, Wong-Sterling S, Silva C, Avitzur Y, Wales PW, Hulst JM, Kong D, Xu L, Li Y, Courtney-Martin G. Reduced strength is associated with abnormal body composition in children with a history of intestinal failure. J Pediatr Gastroenterol Nutr. 2026 Feb;82(2):615-624. doi: 10.1002/jpn3.70307. Epub 2025 Dec 9.
Glenda Courtney-Martin, PhD
The Hospital for Sick Children
70 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2020
First Posted
November 2, 2020
Study Start
October 20, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
March 2, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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