The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
NCT Number: NCT05909228
Poor bone health is a well-recognized but poorly understood complication in children with intestinal failure (IF) who are dependent on parenteral nutrition (PN). Previously, we showed that children with IF have decreased bone turnover markers. It is currently unknown if optimization of parenteral nutrition is related to improved bone turnover markers. Serum concentrations of bone markers (osteocalcin, bone-specific alkaline phosphatase and c-telopeptide) will be measured in 30 IF patients treated at a multidisciplinary intestinal rehabilitation and home PN program at the Hospital for Sick Children and compared to bone markers in 30 age- and sex-matched healthy controls.
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Notify Me6 week–18 year
All sexes
Observational
Toronto, Ontario, M5G 1X8, Canada
It is currently unknown if optimization of PN mixtures leads to a measurable change in bone turnover markers. Our hypothesis is that bone turnover markers of children with IF whose PN has been optimized will not differ from those of healthy control subjects, with a positive effect on bone mineral density.
Our aims are:
To be able to answer these aims, bone markers in children with IF will be compared to bone markers in healthy controls, age- and sex-matched.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
are as follows:
In order to be eligible to participate in this study, a patient must meet all of the following criteria at time of inclusion:
For healthy controls the inclusion criteria are as follows:
A patient who meets any of the following criteria will be excluded from participation in this study:
For healthy controls, the exclusion criteria are as follows:
Time frame: Baseline
To measure serum osteocalcin levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.
Time frame: Baseline
To measure serum C-telopeptide levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.
Time frame: Baseline
To measure serum bone-specific alkaline phosphatase levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.
Time frame: DXA scan results will be collected when performed within 6 months of the blood draw for the bone markers.
Association of serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase with bone mineral density Z-scores for lumber spine and total body less head obtained from DXA scans performed as standard clinical care.
Time frame: Baseline
Association of intestinal failure and parenteral nutrition related factors such as duration of parenteral nutrition (y) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.
Time frame: Intestinal failure and parenteral nutrition related factors
Association of intestinal failure and parenteral nutrition related factors such as parenteral nutrition dependency index (%) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.
The Hospital for Sick Children
Other
Bone Turnover Markers in Children With Intestinal Failure After Optimization of Parenteral Nutrition
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