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Markers of Bone Disease in Children on Parenteral Nutrition

NCT01603472 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2013-07-29

No results posted yet for this study

Summary

Parenteral nutrition (PN) is the provision of nutrients via the intravenous route. Parenteral nutrition associated metabolic bone disease (MBD) was first described in children in the 1980s. Since then, there has been little to no research into the underlying relationship and as a result, little evidence on which to base clinical care. In adults, MBD is associated with increased fractures. At the Hospital for Sick children in Toronto, an intestinal failure program has been set up since 2003. This is the only intestinal failure program in Canada and receives country wide referrals. Most of the patients have short bowel syndrome (SBS) and require PN for prolonged periods, or for life. About 90% of these patients have MBD, and some have had bone fractures. An understanding of the etiology of MBD would provide information to guide care, and prevent this condition. Funding for this area of research however is challenging because intestinal failure requiring long term PN is a rare condition, accounting for approximately 200 - 300 children in all of Canada. The goal of this study therefore is to gather pilot data on markers of MBD in children on long term PN, and to compare these markers to age and gender matched control patients who are fed by mouth or feeding tube. The information gathered from this study will help us begin to understand what is actually happening in the bones of children on long term PN and will form the basis for future studies and improved clinical care.

Conditions

  • Metabolic Bone Disease

Sponsors & Collaborators

  • Rare Disease Foundation, Vancouver, Canada

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Glenda Courtney-Martin · The Hospital for Sick Children

Eligibility

Min Age
6 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-09-30
Completion
2012-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01603472 on ClinicalTrials.gov